BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH BD PRECISIONGLIDE NEEDLE

    MDR report key: 9534283 · Received December 31, 2019

    Report

    Report Number
    8041187-2019-01049
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 10, 2019
    Report Date
    January 6, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS AND 129 ACTUAL SAMPLES WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE PHOTOS AND SAMPLES IT WAS OBSERVED THAT THERE WAS UNCLEAR PERFORATION CUT LINES IN BETWEEN THE BLISTER PACKAGES WHICH WOULD CAUSE THE TEARS AND MAKING THE PACKAGES DIFFICULT TO TEAR; THEREFORE THE INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. AT THE PACKAGING PERFORATION STATION, THERE IS A PERFORATION KNIFE TO CREATE PERFORATED CUTS. BASED ON THE INVESTIGATION, THE PROBABLE ROOT CAUSE COULD BE DUE TO THE PERFORATION KNIFE WEAR AND TEAR, CAUSING THE UNCLEAR PERFORATION CUT LINES AND THE PRODUCTION TECHNICIAN MAY HAVE BEEN UNABLE TO DETECT THE GOOD AND BAD PERFORATION CUT LINES, HENCE PARTS FLOW TO NEXT PROCESS. AN EXTRA VISUAL INSPECTION WILL BEEN DONE TO ENSURE CORRECT PERFORATION LINES ARE ON THE PACKAGING.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAS BEEN FOUND EXPERIENCING 387 OCCURRENCES OF POOR PERFORATION BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PACKAGING CUTTING LINE IS DIFFICULT TO TEAR THE CUTTING LINE OF SERIES PACKAGING IS NOT EASY TO TEAR, AND IT IS EASY TO CAUSE THE PACKAGE TO TEAR.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9147914. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-05-27. MEDICAL DEVICE LOT #: 9204689. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-07-23. MEDICAL DEVICE LOT #: 8142261. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-05-22. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAS BEEN FOUND EXPERIENCING 387 OCCURRENCES OF POOR PERFORATION BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PACKAGING CUTTING LINE IS DIFFICULT TO TEAR THE CUTTING LINE OF SERIES PACKAGING IS NOT EASY TO TEAR, AND IT IS EASY TO CAUSE THE PACKAGE TO TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331700 BD SYRINGE WITH BD PRECISIONGLIDE NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other