BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9548835 · Received January 3, 2020

    Report

    Report Number
    8041187-2019-01068
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    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: ONE PHOTO AND 35 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 DIFFICULTY TO OPEN OCCURRED WITH SYRINGES 10ML E/T 22G 1-1/2IN TW. 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. AND THE PAPER IN THE PACKAGE IS CUT, AND THE WATERPROOF FILM ON THE OTHER SIDE IS NOT CUT." 35 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    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. MEDICAL DEVICE LOT #: 9147985. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-05-27. 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 DIFFICULTY TO OPEN OCCURRED WITH SYRINGES 10ML E/T 22G 1-1/2IN TW. 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. AND THE PAPER IN THE PACKAGE IS CUT, AND THE WATERPROOF FILM ON THE OTHER SIDE IS NOT CUT." 35 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12402 SYRINGE 10ML E/T 22G 1-1/2IN TW SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) SEE. H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other