BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE

    MDR report key: 7070416 · Received November 30, 2017

    Report

    Report Number
    1911916-2017-00360
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    October 5, 2017
    Report Date
    March 1, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903053101
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: NO PHOTOS OR SAMPLES WERE RECEIVED IN THE (B)(4) PLANT FOR EVALUATION THEREFORE FAILURE MODE COULD NOT BE VERIFIED AND ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. CAPA NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 10/11/2017 VIA MEDWATCH #5072679. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE, A BD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE DID NOT RETRACT COMPLETELY WHICH RESULTED IN A PATIENT RECEIVING A SUPERFICIAL SCRATCH ON HER THIGH WHEN THE SYRINGE WAS BEING PULLED AWAY. THE TIP OF THE NEEDLE WAS STILL OUTSIDE THE HUB OF THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852528 BD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE SYRINGE WITH NEEDLE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 6048798 30382903053101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other