BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ POSIFLUSH

    MDR report key: 8199975 · Received December 27, 2018

    Report

    Report Number
    9616657-2018-00074
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    October 25, 2018
    Report Date
    January 7, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K141311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: LOT NUMBER 8192991 WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. DURING THE PRODUCTION PROCESS OF LOT NUMBER 8192991, THERE WAS ONE DOCUMENTED NON-CONFORMANCE THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEFECT. ALTHOUGH A SAMPLE WAS NOT RETURNED FOR THIS SPECIFIC QUALITY RECORD, DEFECTIVE PLUNGER MOVEMENT WAS OBSERVED WITHIN PREVIOUS RETURNED SAMPLES OF THE SAME LOT NUMBER. 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 A PLUNGER OF BD¿ POSIFLUSH WAS DIFFICULT TO MOVE DURING USE.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (DATE) VIA MEDWATCH # 5081661. 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 A PLUNGER OF BD¿ POSIFLUSH WAS DIFFICULT TO MOVE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037554 BD¿ POSIFLUSH VASCULAR CATHETER FLUSH SYRINGE FOZ BECTON, DICKINSON AND CO. 8192991 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other