BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM

    MDR report key: 12055651 · Received June 23, 2021

    Report

    Report Number
    1920898-2021-00688
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. INVESTIGATION SUMMARY : EXEC SUMMARY - SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. SAMPLES RETURNED - THE CUSTOMER RETURNED FIVE SYRINGES WITH A POUCH LABELED FOR 0.3ML, 31 GAUGE, 8MM SYRINGES FROM LOT # 0132204. THE FIRST SYRINGE HAD ITS NEEDLE SHIELD AND HUB SEPARATE FROM THE BARREL. THE HUB HAS BECOME LODGED INSIDE THE SHIELD. THERE IS NO DAMAGE TO EITHER THE CONNECTOR AT THE DISTAL TIP OF THE BARREL OR ITS RESPECTIVE NEEDLE HUB. NO SIGNS OF USE AND NO OTHER DEFECTS WERE FOUND. BASED ON THE SAMPLES RECEIVED, BD FOUND ONE INCIDENCE OF NEEDLE HUB SEPARATION. CAPA/SA - CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE. DHR REVIEW - A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0132204. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 SYRINGE 0.3ML 31GA 8MM HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : IT WAS REPORTED BY THE CONSUMER TO THE BD INVESTIGATION TEAM THAT THE SAMPLES PROVIDED BY THE CUSTOMER HAD A NEEDLE HUB SEPARATION DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944429 SYRINGE 0.3ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0132204

    Patients

    Seq Age Sex Outcome Treatment
    1