BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LS 23GA 1-1/4IN TW

    MDR report key: 9953702 · Received April 13, 2020

    Report

    Report Number
    8041187-2020-00204
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Date of Event
    March 14, 2020
    Report Date
    May 19, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-04-21. H.6. INVESTIGATION SUMMARY THREE PHOTOS AND ONE ACTUAL SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION SLIGHT FLASHES ON THE PLUNGER RIB WERE OBSERVED; THEREFORE, THE INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. THE SAMPLE WAS SUBJECTED TO FLASHES AND MISMATCH MEASUREMENT AND THE PRODUCT IS WITHIN PRODUCT SPECIFICATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: THE EVENT DESCRIPTION HAS BEEN UPDATED WITH A NEW MEDICAL DEVICE BRAND NAME. D.1. MEDICAL DEVICE BRAND NAME: SYRINGE 5ML LS 23GA 1-1/4IN TW. D.2. MEDICAL DEVICE CATALOG #: 302131. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.10. DEVICE AVAILABLE FOR EVAL? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 5ML LS 23GA 1-1/4IN TW HAD MOLDING DEFECTS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITHOUT SMOOTHLY CUTTING EDGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 5ML LS 23GA 1-1/4IN TW HAD MOLDING DEFECTS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITHOUT SMOOTHLY CUTTING EDGE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LS 23G 1-1/4IN TW HAD MOLDING DEFECTS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITHOUT SMOOTHLY CUTTING EDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419517 SYRINGE 5ML LS 23GA 1-1/4IN TW SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other