BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PRN ADAPTER

    MDR report key: 15225771 · Received August 15, 2022

    Report

    Report Number
    3014704491-2022-00353
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 13, 2022
    Report Date
    August 5, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1173181. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. BASED ON THE DESCRIPTION OF THE EVENT AND PREVIOUS INVESTIGATIONS INTO THIS PRODUCT FAMILY OUR ENGINEER SHAVE DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE PRESENCE OF SILICONE RESIDUE ON THE SLEEVE STOPPER. SILICONE IS USED IN THE MANUFACTURE OF THIS DEVICE AND CAN REDUCE THE FRICTION IMPARTED ON THE SURFACE OF THE SLEEVE STOPPER. TO MONITOR OCCURRENCE SUCH AS THESE OUR TEAM IMPLEMENTS A PULL TEST TO CONFIRM THAT THE SLEEVE STOPPER IS PROPERLY FIXED INTO ITS POSITION; WE HAVE INCREASED THE FORCE REQUIREMENTS FOR THIS TEST AS WELL AS UPDATED OUR FINISHED GOODS INSPECTION LIST AND ADJUST TEMPERATURE SETTINGS ON THE HEAT TUNNELS TO INCREASE THE GRIP OF THE SLEEVE STOPPER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ PRN ADAPTER STOPPER FELL OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE INFUSION NEEDLE WAS CONNECTED TO THE PRN AND THEN THE TUBE WAS RINSED, THE YELLOW STOPPER OF THE PRN FELL OFF, AND THE HEPARIN CAP WAS REPLACED AND THE INFUSION SET WAS RE-ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941895 BD¿ PRN ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1173181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown