BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11527861 · Received March 19, 2021

    Report

    Report Number
    2243072-2021-00837
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 22, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BECTON DICKINSON
    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 A 3/10CC, 12.7MM, 29G SYRINGE WITH A POLY BAG FROM LOT # 0160988. CUSTOMER STATES THAT WHEN REMOVING THE SHIELD, THERE WAS NO NEEDLE. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FORM THE BARREL.. 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. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES). CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITILA REPORTER: "THE CUSTOMER REPORTED AS FOLLOWS: WHEN REMOVING THE SHIELD, THE HCP NOTICED THAT THERE WAS NO NEEDLE."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN AND (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 A SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITILA REPORTER: "THE CUSTOMER REPORTED AS FOLLOWS: WHEN REMOVING THE SHIELD, THE HCP NOTICED THAT THERE WAS NO NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425156 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1