BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH THE BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 12857356 · Received November 22, 2021

    Report

    Report Number
    1911916-2021-01177
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 19, 2021
    Report Date
    October 28, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903059042
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. MEDICAL DEVICE TYPE: FMI. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980987 (SYRINGE). PMA / 510(K)#: K951254 (NEEDLE). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305904 AND LOT NUMBER 1076335. 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. 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 THAT THE BD LUER-LOK¿ SYRINGE WITH THE BD SAFETYGLIDE¿ NEEDLE HAD ISSUES WITH THE NEEDLE AND SYRINGE SEPARATING AND ALLOWING THE DTAP-IPV VACCINE TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CLIENT WAS IN FOR THE IMMUNIZATIONS. DURING THE ADMINISTRATION OF DTAP-IPV, THE SYRINGE SEPARATED FROM THE HUB OF THE NEEDLE AND VACCINE LEAKED OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750596 BD LUER-LOK¿ SYRINGE WITH THE BD SAFETYGLIDE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 305904 1076335 30382903059042

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown