BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 11750680 · Received April 29, 2021

    Report

    Report Number
    1911916-2021-00389
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 19, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A NEEDLE WAS BEING INSERTED INTO PATIENTS BACK NEAR THE SPINE AND THE NEEDLE BROKE OFF INTO PATIENT. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305136 AND LOT NUMBER 9093947. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS PRODUCT AND SYMPTOM. WITH NO SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED A NEEDLE THAT BROKE. THE PATIENT WAS TRANSPORTED TO RECEIVE "NEEDLE REMOVAL SURGERY" AFTER A PORTION OF THE DEVICE BECAME EMBEDDED WITHIN PATIENT, NEAR THE SPINE. ADDITIONAL DETAILS REGARDING THE NEEDLE REMOVAL SURGERY AND ITS OUTCOME HAVE NOT BEEN PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305136, BATCH NO: 9093947, NEEDLE WAS BEING INSERTED INTO PATIENTS BACK NEAR SPINE AND NEEDLE BROKE OFF INTO PATIENT. PATIENT WAS TRANSPORTED BY EMS TO HOSPITAL FOR NEEDLE REMOVAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646307 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9093947

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention