BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS/SF

    MDR report key: 20556406 · Received October 29, 2024

    Report

    Report Number
    9616657-2024-00030
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    September 27, 2024
    Report Date
    December 12, 2024
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    00382903065721
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 4071870. THE REVIEW DID NOT REVEAL ANY NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PHYSICAL SAMPLES AND PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PHYSICAL SAMPLES, ONE (1) SAMPLE WAS FOUND TO DISPLAY THE ISSUE OF TORN PACKAGING. REGARDING THE TORN PACKAGING, A SIGNIFICANT AMOUNT OF IN PROCESS TESTING IS PERFORMED DURING THE MANUFACTURE OF EACH POSIFLUSH LOT. THE BLISTER PACK MACHINE OPERATOR CHECKS TWENTY UNITS PER HOUR AND THE SECONDARY PACKING OPERATOR CHECKS A FURTHER THIRTY UNITS PER STERI-CYCLE. IN ADDITION, FINAL INSPECTION IS PERFORMED ON THIRTY UNITS PER PALLET BY QUALITY CONTROL INSPECTORS. THERE WERE NO REPORTS OF POOR PERFORATIONS DURING ANY OF THESE INSPECTIONS. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED AT THIS TIME. PREVIOUS INVESTIGATIONS HAVE IDENTIFIED THAT THIS DEFECT MAY BE CAUSED BY THE INCORRECT METHOD OF SEPARATION. IT IS RECOMMENDED THAT BLISTERS ARE SEPARATED ON A HORIZONTAL PLANE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. 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. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH XS/SF POUCH PERFORATION WITH SEAL BREECH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 X CUT THROUGH SEAL OVER SEPARATING INDIVIDUALLY. I CAN CONFIRM THERE IS NO IMPACT TO PATIENT AS DAMAGE WAS IDENTIFIED DURING GOODS IN INSPECTION, THERE IS ALSO NO CONTAMINATION OF BLOOD OR CYTOTOXIC MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303416 BD POSIFLUSH XS/SF SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 4071870 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown