BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PRECISIONGLIDE¿ 27 G X 1-1/4" HYPODERMIC NEEDLES

    MDR report key: 15346165 · Received September 2, 2022

    Report

    Report Number
    1911916-2022-00480
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 10, 2022
    Report Date
    August 17, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051366
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305136 AND LOT NUMBER 2021694. 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. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PRECISIONGLIDE¿ 27 G X 1-1/4" HYPODERMIC NEEDLES THE NEEDLE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305136 BATCH # 2021694. IT WAS REPORTED THAT THE NEEDLE BROKE WHILE ADMINISTERING A SHOT. VERBATIM: BD1 - 305136 - LOT:2021694 - NEEDLE BROKE WHILE NURSE WAS GIVING SHOT. NEEDLE BROKE OFF FROM HUB WHILE IN PATIENT BODY. PATIENT REQUIRING TO HAVE SURGICAL INTERVENTION TO REMOVE NEEDLE THAT BROKE OFF IN HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831799 BD PRECISIONGLIDE¿ 27 G X 1-1/4" HYPODERMIC NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 2021694 00382903051366

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O