BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE¿ PEN NEEDLE

    MDR report key: 7359761 · Received March 21, 2018

    Report

    Report Number
    3006948883-2018-00033
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    March 3, 2018
    Report Date
    April 16, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY:A SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS EVALUATED AND BD WS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE.DHR OF LOT 7123163 WAS REVIEWED WITH NO ABNORMALITIES FOUND.RETAINED SAMPLES WERE CHECKED AND ALL CANNULAS MET THE QUALITY REQUIREMENT. MANUFACTURING PERFORMS A 100% VISION INSPECTION ON THE CANNULA AND DID NOT HAVE ANY QUALITY ISSUES ACCORDING TO THE DHR REVIEW.INVESTIGATION CONCLUSION:BD WAS ABLE TO CONFIRM THE INDICATED FAILURE MODE. THERE IS NO EVIDENCE TO CONFIRM A MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INJECTION, A (B)(6) YEAR OLD CHILD MOVED AND THE BD MICRO-FINE¿ PEN NEEDLE BROKE OFF INTO THE CHILD¿S ABDOMEN. THE CHILD WAS TAKEN TO THE HOSPITAL FOR IMAGING AND THE NEEDLE WAS REMOVED VIA SURGERY. THE PATIENT HAS BEEN DISCHARGED AND NO OTHER MEDICAL INTERVENTIONS ARE SUSPECTED TO BE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199365 BD MICRO-FINE¿ PEN NEEDLE PEN NEEDLE FMI BD (SUZHOU) 7123163

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention