BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN

    MDR report key: 11897723 · Received May 27, 2021

    Report

    Report Number
    1920898-2021-00608
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 30, 2021
    Report Date
    June 21, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED SEVERAL IMAGES OF A SINGLE SYRINGE WITH A POLYBAG IDENTIFYING IT AS A 0.3ML, 29 GAUGE, 12.7MM SYRINGE FROM LOT 0160988. THE SYRINGE HAS 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 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. CAPA#1630423 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    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 THE NEEDLE/SHIELD SEPARATION FROM THE BARREL WHEN REMOVING THE ORANGE SHIELD.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE# : (B)(6). A DEVICE EVALUATION IS PENDING 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 THE NEEDLE/SHIELD SEPARATION FROM THE BARREL WHEN REMOVING THE ORANGE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791243 SYRINGE 0.3ML 29GA 1/2IN PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0160988

    Patients

    Seq Age Sex Outcome Treatment
    1