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OPQ reviews syringe–connector incompatibility cases and agency responses
Summary
The presenter described multiple case studies where syringe–connector incompatibilities led to field alerts and label changes; she said FDA has received adverse-event reports and recommended early applicant interaction and joint meetings with CDER and CDRH.
The presenter introduced a multi-part case study on incompatibilities between syringes (glass-barrel) and certain lower-activated connectors. She noted FDA has addressed the issue over time with labeling updates and field alerts and said: "FDA continue to receive additional reports of adverse events related to syringe malfunction and clothing." The presenter described two product examples: Product A (glass lower-lock adapter) prompted major deficiencies and field alerts early in review; Product B (polycarbonate adapter) was assessed as low user-interface risk and required no labeling warning.
She described incident reports (a medication leak in one scenario and a syringe detachment in another) shown in a 2024 medication-safety alert image. Applicants responded with labeling cautions listing acceptable lower-activated connectors or by proposing to replace glass-barrel syringes with prefilled syringes and submitting supporting data; in some cases these responses eliminated the need for a warning statement on the label.
