BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 29GA 1/2IN

    MDR report key: 12635197 · Received October 14, 2021

    Report

    Report Number
    1920898-2021-01077
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 16, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED SEVERAL IMAGES OF 5 SYRINGES ALONGSIDE A POLYBAG LABELED FOR 0.3ML, 29 GAUGE, 12.7MM SYRINGES FROM LOT 0160988. THE SYRINGES HAVE HAD THEIR NEEDLE SHIELDS AND HUBS SEPARATE FROM THEIR RESPECTIVE BARRELS. THE HUBS HAVE BECOME LODGED INSIDE THE SHIELDS. THERE IS NO DAMAGE TO EITHER THE CONNECTORS AT THE DISTAL TIPS OF THE BARRELS OR THEIR RESPECTIVE NEEDLE HUBS. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160988. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE IMAGES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION IN ALL 5 SHOWN SAMPLES. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SYRINGE 0.3ML 29GA 1/2IN HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED ABOUT NEEDLE AND SHIELD SEPARATION FROM THE BARREL WHEN REMOVING THE SHIELD.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD SYRINGE 0.3ML 29GA 1/2IN HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED ABOUT NEEDLE AND SHIELD SEPARATION FROM THE BARREL WHEN REMOVING THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533002 BD SYRINGE 0.3ML 29GA 1/2IN PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0160988

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown