BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH SYRINGE

    MDR report key: 18835622 · Received March 5, 2024

    Report

    Report Number
    9616657-2024-00009
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 13, 2024
    Report Date
    March 25, 2024
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURES AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE SYRINGE WAS REMOVED FROM THE ORIGINAL PACKAGING AND EXAMINED, CONFIRMING THE PRESENCE OF FOREIGN MATTER. THE SAMPLE WAS SENT FOR ATTENUATED TOTAL REFLECTANCE-FOURIER TRANSFORM INFRARED (ATR-FTIR) ANALYSIS TO IDENTIFY THE FOREIGN MATTER COMPOSITION. THE RESULTS DETERMINED THAT THE FOREIGN MATTER WAS AN EMBEDDED CELLULOSE MATERIAL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546 AND LOT NUMBER 3242978. THE REVIEW DID NOT REVEAL ANY DETECTED NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. FOLLOWING OUR INVESTIGATION, WE CANNOT IDENTIFY A DEFINITIVE ROOT CAUSE; HOWEVER, DUE TO THE DEGRADED CONDITION OF THE EMBEDDED FOREIGN MATTER IN THE BARREL, IT MOST LIKELY ENTERED PRIOR TO THE MOLDING PROCESS. THIS IS THE FIRST REPORT RECEIVED FOR THIS TYPE OF DEFECT ON MATERIAL NUMBER 306546 AND LOT NUMBER 3242978, OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER NOTED SOME TYPE OF DEBRIS WITHIN THE FLUSH SYRINGE. THIS WAS IDENTIFIED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882088 BD POSIFLUSH SYRINGE SALINE VASCULAR ACCESS FLUSH FOZ BECTON, DICKINSON AND CO. 3242978 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown