BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML E/T 22G 1-1/2IN

    MDR report key: 9491356 · Received December 18, 2019

    Report

    Report Number
    8041187-2019-01022
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    December 3, 2019
    Report Date
    January 14, 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: ONE PHOTO AND SEVEN ACTUAL SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE PHOTO 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-CONFORMANCES 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 WAS REPORTED THAT THERE WAS POOR PERFORATION ON PACKAGE WITH A BD SYRINGE 10ML E/T 22G 1-1/2IN. THIS OCCURRED ON 6 SEPARATE OCCASIONS PRIOR TO USE WITH BATCH # 9114589. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUTTING LINE OF THE BAG IS DIFFICULT TO TEAR AND EASY TO BREAK THAT OFTEN OCCURS IN THE SECOND AND THIRD BRANCHES OF THE PACKAGING SERIES.

    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 #: 9114589. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-04-24. MEDICAL DEVICE LOT #: 9171737. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2019-06-20." 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 THERE WAS POOR PERFORATION ON PACKAGE WITH A BD SYRINGE 10ML E/T 22G 1-1/2IN. THIS OCCURRED ON 6 SEPARATE OCCASIONS PRIOR TO USE WITH BATCH # 9114589. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUTTING LINE OF THE BAG IS DIFFICULT TO TEAR AND EASY TO BREAK THAT OFTEN OCCURS IN THE SECOND AND THIRD BRANCHES OF THE PACKAGING SERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286584 BD SYRINGE 10ML E/T 22G 1-1/2IN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other