BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECT

    MDR report key: 6001993 · Received October 5, 2016

    Report

    Report Number
    9614709-2016-00002
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 5, 2016
    Manufacturer
    DR. JAPAN CO. LTD.
    Product Code
    BSP
    PMA / PMN Number
    K990519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFECT DEVICE WAS NOT RETURNED TO THE FACTORY FOR EVALUATION. AT THIS TIME THE LOT NUMBER OF THE DEVICE IS NOT AVAILABLE, SO OUR INVESTIGATION ABILITY WILL BE LIMITED. IF THE DEVICE IS RETURNED OR ADDITIONAL DETAILS BECOME AVAILABLE REGARDING LOT INFORMATION, WE WILL INVESTIGATE ACCORDINGLY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, WE WILL SUBMIT A FOLLOW UP REPORT TO INCLUDE THE CORRECTED DATA.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER, DR. JAPAN WAS NOTIFIED OF THE COMPLAINT REPORTED. DUE TO THE CUSTOMER FAILING TO PROVIDE THE LOT NUMBER FOR THIS REPORTED EVENT, THE MANUFACTURER COULD NOT CONDUCT AN APPROPRIATE INVESTIGATION OF THE REPORTED DEVICE. ALTHOUGH THE DEFECTIVE DEVICE WAS NOT AVAILABLE FOR THE MANUFACTURER TO EXAMINE, THE LISTED ROOT CAUSE WAS CONVEYED BY THE MANUFACTURER FOR THIS EVENT: ROOT CAUSE: A REPAIR WAS MADE TO THE PLUNGER (STYLET) MOLD OF THE DEVICE IN THE AREA OF THE RIB BY THE CONTRACT MANUFACTURER. THE RESULTING MOLD DIMENSION OF THE PLUNGER (STYLET) RIB WAS TOO BIG (AN EXCESS OF MATERIAL WS REMOVED). THIS CAUSED THE FIT BETWEEN THE PLUNGER (STYLET) AND THE NEEDLE HUB. CORRECTIVE ACTION: THE MOLD OF THE PLUNGER (STYLET) RIB WAS REPLACED AND RESULTED IN A LOOSER FIT BETWEEN THE PLUNGER (STYLET) AND THE NEEDLE HUB. THE FOLLOWING WERE CORRECTED WITHIN THIS MDR FOLLOW-UP REPORT: OPERATOR OF DEVICE - INFORMATION WAS INADVERTENTLY OMITTED DURING THE INITIAL REPORTING OF THIS EVENT. THE ADDRESS OF THE IMPORTER ((B)(4)) HAS BEEN UPDATED FROM (B)(4) TO (B)(4) TO REFLECT THE IMPORTER'S NEW LOCATION. FOLLOW-UP CHOICE SELECTED IN THIS FIELD TO UPDATE THIS REPORT AS A FOLLOW-UP #001. DATE RECEIVED BY MANUFACTURER FIELD UPDATED TO REFLECT THE CURRENT DATE OF 04/18/2017 FOR THIS FOLLOW-UP REPORT BEING SENT TO THE MANUFACTURER. 'CORRECTION' AND 'ADDITIONAL INFORMATION' SELECTED TO DESCRIBE THIS TYPE OF FOLLOW-UP REPORT BEING SUBMITTED HERE. (B)(4) ADDED TO CAPTURE ADDITIONAL DEVICE CODE ASSOCIATED WITH THE REPORTED MALFUNCTION. BASED OFF THE MANUFACTURER'S ROOT CAUSE AND CORRECTIVE ACTION PROVIDED, WE ARE MOVING TO CLOSE THE COMPLAINT FILE AND CONSIDER THIS MDR CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE WAS STICKING. THERE IS LITTLE DETAIL BEYOND THE REPORT BUT IT IS ASSUMED THE CUSTOMER IS REFERRING TO THE NEEDLE STYLET BEING DIFFICULT TO PULL OUT OF THE NEEDLE HUB. NO DEFECT DEVICE HAS BEEN RETURNED FOR EVALUATION, AND THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE WAS STICKING. THERE IS LITTLE DETAIL BEYOND THE REPORT BUT IT IS ASSUMED THE CUSTOMER IS REFERRING TO THE NEEDLE STYLET BEING DIFFICULT TO PULL OUT OF THE NEEDLE HUB. NO DEFECT DEVICE HAS BEEN RETURNED FOR EVALUATION, AND THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651662 SELECT SPINAL NEEDLE BSP DR. JAPAN CO. LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1