BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTIP

    MDR report key: 8409398 · Received March 11, 2019

    Report

    Report Number
    1058382-2019-00002
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 11, 2019
    Manufacturer
    DR. JAPAN CO. LTD.
    Product Code
    BSP
    UDI-DI
    00817781020079
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMPORTER SUMMARY: THE MANUFACTURER CONDUCTED AN INVESTIGATION AND WAS UNABLE TO DETERMINE A ROOT CAUSE AS THE ACTUAL DEVICE WAS UNAVAILABLE FOR THE INVESTIGATION, BUT A PHOTO OF THE DEFECT DEVICE WAS PROVIDED BY THE END-USER. UNUSED SAMPLES RETURNED BY THE END-USER WERE 100% VISUALLY INSPECTED BUT DID NOT EXHIBIT THE DEFECT REPORTED. THE MANUFACTURER CONCLUDED THE DEFECT CONDITION MAY HAVE OCCURRED AFTER BEING SHIPPED FROM THE FACTORY, AS JIGS USED DURING THE MANUFACTURING PROCESS WOULD NOT PHYSICALLY ALLOW FOR SUCH A CONDITION TO OCCUR. FURTHER, AT THE TIME OF MANUFACTURE OF THIS LOT (NON-STERILE LOT#37864) RAW MATERIAL FOR STYLETS LONGER THAN 3.5" INCHES WAS NOT AVAILABLE FOR PRODUCTION. (SEE THE ATTACHED MANUFACTURER INVESTIGATION REPORT) A FOLLOW UP INVESTIGATION WAS REQUESTED AT THE CONTRACT PACKAGER AFTER THE MANUFACTURER'S INVESTIGATION WAS COMPLETED. SINCE THE MANUFACTURER CONCLUDED THE DEFECT DID NOT OCCUR IN THEIR FACILITY, THE NEXT LOGICAL OPPORTUNITY WOULD OCCUR DURING THE HANDLING OF THE NEEDLE WHILE PERFORMING THE PACKAGING. WE REQUESTED THE CONTRACT PACKAGER CONDUCT AN INVESTIGATION. THEY STATED THEIR PROCESS WOULD NOT ALLOW FOR THIS TYPE OF DEFECT TO OCCUR AND WOULD BE DIFFICULT TO SEE IF THE LONGER STYLET WAS PRESENT DURING THE PACKING STAGE. AS THEY ONLY TRANSFER THE NEEDLE TO THE MULTIVAC CAVITY DURING PACKAGING, THEY CONCLUDED THE DEFECT WAS NOT CAUSED DURING THIS PROCESS (SEE ATTACHED THE LETTER FROM THE CONTRACT PACKAGER). WE REGRET WE ARE UNABLE TO OFFER A DEFINITIVE EXPLANATION WITH THE INFORMATION AND UNUSED SAMPLES PROVIDED. BOTH THE MANUFACTURER AND PACKAGER SUBCONTRACTOR WERE MADE AWARE OF THE REPORTED DEFECT BUT WERE UNABLE TO PROVIDE A ROOT CAUSE OR CORRECTIVE ACTION. WE HAVE NOT RECEIVED ANY SIMILAR COMPLAINTS FOR THIS ISSUE AND CAN ASSUME THE DEFECT IS LIMITED TO A SMALL NUMBER OF SAMPLES REPORTED BY THIS END-USER. REPLACEMENT PRODUCT SUPPLIED TO THE END-USER HAS TO DATE NOT EXHIBITED THIS DEFECT, AND WE HAVE REQUESTED THAT IF FOUND AGAIN THE SAMPLE BE RETAINED FOR EXAMINATION. WE ARE MOVING TO CLOSE THIS COMPLAINT BASED ON THE INVESTIGATION RESULTS OF THE NEEDLE MANUFACTURER, AND THE INVESTIGATION CONDUCTED AT THE PACKAGING CONTRACTOR. WE WILL CONTINUE TO MONITOR OUR FEEDBACK SYSTEM FOR ANY SIMILAR REPORTS, UPDATE THE MANUFACTURER AND OUR COMPLAINT FILE WITH ANY ADDITIONAL INFORMATION, AND TAKE ANY NECESSARY ADDITIONAL ACTION AT THAT TIME. WE CONSIDER THIS REPORT TO BE CLOSED. - ATTACHMENT: [CPL#19030601.01_IMG.PDF, CPL#19030601.38_MFG INVESTIGATION REPORT.PDF, CPL#19030601.39_EAGLE RESPONSE LETTER.PDF].

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE INTRODUCER (STYLET) WAS LONGER THAN THE NEEDLE CANNULA BY APPROXIMATELY ONE-HALF (0.5) INCH. AS THE DEFECT WAS DISCOVERED PRIOR TO USE, THERE WAS NO RISK TO THE PATIENT AS THE NEEDLE WAS NOT USED. THE DEFECT DEVICE WAS NOT AVAILABLE FOR EXAMINATION, HOWEVER A PHOTO WAS PROVIDED OF THE DEFECT DEVICE. THE CLINIC IS RETURNING THE UNUSED PRODUCT AND IT WILL BE EXCHANGED FOR A DIFFERENT LOT OF THE SAME SIZE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE INTRODUCER (STYLET) WAS LONGER THAN THE NEEDLE CANNULA BY APPROXIMATELY ONE-HALF (0.5) INCH. AS THE DEFECT WAS DISCOVERED PRIOR TO USE, THERE WAS NO RISK TO THE PATIENT AS THE NEEDLE WAS NOT USED. THE DEFECT DEVICE WAS NOT AVAILABLE FOR EXAMINATION; HOWEVER, A PHOTO WAS PROVIDED OF THE DEFECT DEVICE. THE CLINIC IS RETURNING THE UNUSED PRODUCT AND IT WILL BE EXCHANGED FOR A DIFFERENT LOT OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199873 ACCUTIP SPINAL NEEDLE BSP DR. JAPAN CO. LTD. 80503DV 00817781020079

    Patients

    Seq Age Sex Outcome Treatment
    1