BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 10785841 · Received November 4, 2020

    Report

    Report Number
    1920898-2020-01524
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 14, 2020
    Report Date
    April 9, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 3/10CC, 12.7MM, 29G SYRINGES IN POLY BAGS FROM LOT # 0052894. CUSTOMER STATES THAT WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIELD WAS SEPARATED FROM THE BARREL. THE PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0052896 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED FOR CRACKED HUBS CRACKED AND RAISED HUBS; BOTH DEFECTS MAY CAUSE THE NEEDLE ASSEMBLY UNIT TO NOT SNAP FIT ONTO THE BARREL. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. FDA DEVICE PROBLEM CODE(S): 1354. FDA PATIENT PROBLEM CODE(S): 2199.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254229 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 0052896

    Patients

    Seq Age Sex Outcome Treatment
    1