BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 6MM

    MDR report key: 11852785 · Received May 19, 2021

    Report

    Report Number
    9614033-2021-00059
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : CUSTOMER RETURNED MULTIPLE IMAGES. THE IMAGES SHOW A NEEDLE SHIELD AND NEEDLE HUB SEPARATED FROM THE BODY OF THEIR SYRINGE. THERE ARE NO IMAGES OF THE BARREL OF THE SYRINGE, BUT THE CONDITION OF THE SHIELD AND HUB ARE IN LINE WITH STANDARD NEEDLE HUB SEPARATION. THE REMAINING IMAGES SHOW THE SHELF CARTON AND POLYBAG, IDENTIFYING THE SYRINGE AS BEING A 0.3ML, 31 GAUGE, 6MM SYRINGE FROM LOT 0132196. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0132196. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION 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. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SYRINGE 0.3ML 31G 6MM HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT A SYRINGE WENT WRONG, THE PART OF THE NEEDLE IS STUCK IN THE CAP AND DOES NOT COME OUT. THE CUSTOMER REPORTED 1 AFFECTED PIECE.

    Additional Manufacturer Narrative · 1

    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 31G 6MM HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT A SYRINGE WENT WRONG, THE PART OF THE NEEDLE IS STUCK IN THE CAP AND DOES NOT COME OUT. THE CUSTOMER REPORTED 1 AFFECTED PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744486 SYRINGE 0.3ML 31G 6MM PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 0132196

    Patients

    Seq Age Sex Outcome Treatment
    1