BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11520755 · Received March 18, 2021

    Report

    Report Number
    1920898-2021-00314
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 22, 2021
    Report Date
    March 19, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-17. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 3/10CC, 12.7MM, 29G SYRINGE IN AN OPEN POLY BAG FROM LOT # 0160988. CUSTOMER STATES THAT WHEN REMOVING THE ORANGE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A MISSING HUB ASSEMBLY. THE SHIELD WAS RETURNED WITH THE SYRINGE. 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 NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER (ANIMAL CLINIC) REPORTED AS FOLLOWS: WHEN REMOVING THE ORANGE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL. THIS IS OCCURRING FREQUENTLY."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER (ANIMAL CLINIC) REPORTED AS FOLLOWS: WHEN REMOVING THE ORANGE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL. THIS IS OCCURRING FREQUENTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417144 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0160988

    Patients

    Seq Age Sex Outcome Treatment
    1