BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN.

    MDR report key: 15972664 · Received December 13, 2022

    Report

    Report Number
    1213809-2022-01228
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 18, 2022
    Report Date
    December 15, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903052715
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 29-NOV-2022. H6: INVESTIGATION SUMMARY : IT WAS REPORTED THE NEEDLES ARE NOT RETRACTING AS INTENDED. TO AID IN THE INVESTIGATION, TWO 3ML 23X1 SYRINGES IN SEALED PACKAGING BLISTERS FROM LOT 9001858 WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. EACH SAMPLE WAS FUNCTIONALLY TESTED. THE REPORTED DEFECT COULD NOT BE CONFIRMED BASED UPON THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305271, LOT NUMBER 9001858. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 9001858 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN.THE SYRINGE DID NOT RETRACT. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 STERILE SEALED PACKAGES AND COMPLAINED ABOUT THE NEEDLES ATTACHED TO THE INTEGRA SYRINGES WHERE NOT RETRACTING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN.THE SYRINGE DID NOT RETRACT. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 STERILE SEALED PACKAGES AND COMPLAINED ABOUT THE NEEDLES ATTACHED TO THE INTEGRA SYRINGES WHERE NOT RETRACTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484244 BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN. PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 305271 9001858 30382903052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown