BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 11515838 · Received March 18, 2021

    Report

    Report Number
    2243072-2021-00825
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 18, 2021
    Report Date
    March 26, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: 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 0.5ML 30GA 1/2IN UF 10BAG 500CS. D.2. COMMON DEVICE NAME: PISTON SYRINGE. D.2. MEDICAL DEVICE CATALOG #: 328466. D.3. MEDICAL DEVICE MANUFACTURER: HOLDREGE. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. D.4. MEDICAL DEVICE LOT #: 9343396. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: HOLDREGE. G.5. PMA/510(K)#: K024112. H.4. DEVICE MANUFACTURE DATE: 2019-12-09.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:UNKNOWN, BATCH NO:UNKNOWN. IT WAS REPORTED THAT THE WHOLE NEEDLE COMPONENT COMES OFF WHEN THE NEEDLE SHIELD IS REMOVED.

    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 UNSPECIFIED BD¿ SYRINGE HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE WHOLE NEEDLE COMPONENT COMES OFF WHEN THE NEEDLE SHIELD IS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418861 SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9343396

    Patients

    Seq Age Sex Outcome Treatment
    1