BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 8552748 · Received April 25, 2019

    Report

    Report Number
    9616657-2019-00198
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    March 19, 2019
    Report Date
    May 21, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR WAS REVIEWED, THE NON-CONFORMANCES WERE REVIEWED FOR THIS BATCH, AND THERE WAS NO RECORD OF ANY NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE. THERE WAS NO SAMPLE RECEIVED HOWEVER, THE PHOTO CONFIRMED BARREL LUER TIP FLASH. THE ROOT CAUSE MAY BE RELATED TO MOULDING PIN WEAR AND INSPECTION AND DETECTION METHODOLOGY INADEQUACY ON THE MOULDING MACHINE. CAPA#733763 WAS INITIATED.

    Description of Event or Problem · 0

    MATERIAL NO: 306572 BATCH NO: 8330636 IT WAS REPORTED THAT BEFORE USE OF THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% THERE WAS A PIECE OF PLASTIC ON THE TIP OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE VISITING QEH HOSPITAL FOR AN IN SERVICE I WAS APPROACHED WITH A SAMPLE OF XS POSIFLUSH 10ML INDICATING THAT THERE WAS A VISIBLE PIECE OF PLASTIC ON THE TIP OF THE SYRINGE SO SHE CAPPED IT WITH A BLUE CAP TO ENSURE THE PLASTIC STAYED INTACT FOR INVESTIGATION. THIS HAS HAPPENED ON MULTIPLE OCCASIONS THAT I WAS NOT MADE AWARE OF UNTIL (B)(6) 2019.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO: 306572 BATCH NO: 8330636. IT WAS REPORTED THAT BEFORE USE OF THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% THERE WAS A PIECE OF PLASTIC ON THE TIP OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE VISITING (B)(6) HOSPITAL FOR AN IN SERVICE I WAS APPROACHED WITH A SAMPLE OF XS POSIFLUSH 10ML INDICATING THAT THERE WAS A VISIBLE PIECE OF PLASTIC ON THE TIP OF THE SYRINGE, SO SHE CAPPED IT WITH A BLUE CAP TO ENSURE THE PLASTIC STAYED INTACT FOR INVESTIGATION. THIS HAS HAPPENED ON MULTIPLE OCCASIONS THAT I WAS NOT MADE AWARE OF UNTIL APRIL 5TH, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343500 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% PRE-FILLED SYRINGE NGT BECTON, DICKINSON AND CO. 8330636

    Patients

    Seq Age Sex Outcome Treatment
    1 Other