BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELI

    MDR report key: 10950317 · Received December 5, 2020

    Report

    Report Number
    1058382-2020-00003
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Report Date
    December 4, 2020
    Manufacturer
    DR. JAPAN CO., LTD.
    Product Code
    BSP
    UDI-DI
    00386120006758
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE MOVING TO CLOSE THIS COMPLAINT BASED ON THE MANUFACTURER'S INVESTIGATION RESULTS. ALTHOUGH THE SUSPECT DEVICE WAS NOT RETURNED BY THE END-USER FOR EXAMINATION, 20 SAMPLES FROM THE SAME STERILE LOT WERE SENT FROM RETAINS FOR THE FACTORY TO EXAMINE AND TEST. PHYSICAL TESTING OF THE RETURNED SAMPLES WAS PERFORMED FOR PULL-OUT STRENGTH OF THE NEEDLE TO NEEDLE HUB BOND, AND THE TEST SAMPLES MET ALL SPECIFICATIONS. IN ADDITION TO THE PHYSICAL TESTING, A REVIEW OF ALL RECORDS WAS CONDUCTED AND NO FAILURES DURING PRODUCTION WERE REPORTED. A COPY OF THE TEST REPORT WILL BE FILED WITH THE FDA TO CLOSE THE MDR REPORT FILED FOR THIS ISSUE. WITHOUT AN EXAMINATION OF THE SUSPECT DEVICE, THE FACTORY WAS UNABLE TO DETERMINE A ROOT CAUSE, AND NO CORRECTIVE ACTION WILL BE IMPLEMENTED AT THIS TIME. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED WITHIN THE PAST 12 MONTHS REVIEWED. WE WILL CONTINUE TO MONITOR OUR FEEDBACK SYSTEM AND TAKE ANY ADDITIONAL ACTION AS NECESSARY. WE CONSIDER THIS REPORT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT THE NEEDLE DISCONNECTED FROM THE HUB DURING A PELVIS INJECTION AND WAS LEFT IN THE PATIENT. IT WAS ALSO REPORTED THIS OCCURED THREE (3) TIMES AND HE HAS USED THESE NEEDLES PREVIOUSLY. HE DID STATE THE AREA IN THE PELVIS REQUIRED HIM TO PUSH HARD INTO THE PATIENT BECAUSE IT WAS A NARROW INJECTION AREA AND WHEN HE PULLED THE NEEDLE OUT IT DISCONNECTED. ALL THREE PATIENTS WERE REPORTED TO BE MODERATELY OBESE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420458 RELI ANESTHESIA NEEDLE BSP DR. JAPAN CO., LTD. SN22G351 1903758 00386120006758

    Patients

    Seq Age Sex Outcome Treatment
    1