BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NS FILLED SYRINGE

    MDR report key: 8166373 · Received December 14, 2018

    Report

    Report Number
    9616657-2018-00068
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 25, 2018
    Report Date
    December 19, 2018
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K141311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE BELONGING TO LOT NUMBER 8192991 WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. THROUGH VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED SAMPLE, IT WAS DETERMINED THAT THE PLUNGER MOVEMENT WAS DEFECTIVE. DHR REVIEW SHOWS THAT DURING THE PRODUCTION PROCESS OF LOT NUMBER 8192991, THERE WAS ONE DOCUMENTED NON-CONFORMANCE THAT COULD HAVE CONTRIBUTED TO THIS DEFECT. DURING PRODUCTION, A DAMAGED SILICONE CANISTER WAS FOUND WITHIN THE SILICONE STATION, WHICH RESULTED IN AN INSUFFICIENT SUPPLY OF SILICONE TO THE SYRINGE BARRELS. PRODUCT ASSOCIATED WITH THIS NON-CONFORMANCE WAS HELD FOR INSPECTION AND ALL AFFECTED MATERIAL SHOULD HAVE BEEN DISCARDED. IT IS POSSIBLE THAT A MISDETECTION IN DEFECTIVE PRODUCT CAUSED THIS INCIDENT, AS THE SAMPLES WERE NOT PROPERLY DISCARDED. THE DAMAGED SILICONE CANISTER HAS SINCE BEEN REPLACED. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER IN THE BD POSIFLUSH¿ NS FILLED SYRINGE WOULDN'T MOVE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER IN THE BD POSIFLUSH¿ NS FILLED SYRINGE WOULDN'T MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003103 BD POSIFLUSH¿ NS FILLED SYRINGE INTRAVASCULAR CATHETER NGT BECTON, DICKINSON AND CO. 8192991 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other