BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RANEY SCALP CLIPS

    MDR report key: 7060063 · Received November 27, 2017

    Report

    Report Number
    1226348-2017-10884
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 6, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. SUPPLIER RESPONSE FOR THE RANEY CLIPS: WE HAVE IMPLEMENTED ADDITIONAL PIECE COUNT CHECKS FOR THIS AREA THROUGHOUT TIME, THE 21 COUNT IS THE ONE THAT IS TOUGHER TO CONNECT WITH A TRUE ROOT CAUSE. THE DHR FOLDERS HAVE BEEN REVIEWED WITH NO INDICATION OF MISS-COUNTS BEING RECORDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. RECEIVED WERE TWO OPEN PACKETS OF SURGICAL PATTIES AND 21 INDIVIDUAL CLIPS. EACH PACK SHOULD CONTAIN 10 CLIPS. BASED ON THE PACKAGE BEING OPENED UPON RECEIPT, WE ARE UNABLE TO CONCLUSIVELY DETERMINE AT WHAT POINT THE REPORTED ISSUE MAY HAVE OCCURRED. ADDITIONALLY, WE CAN ONLY CONFIRM THAT ONE EXTRA CLIP WAS PRESENT IN THE TWO PACKETS. WE ARE UNABLE TO DETERMINE WHICH PACKET CONTAINED THE ADDITIONAL CLIP. A DHR REVIEW FOR THE REPORTED LOTS FOUND NO MANUFACTURING DEFECTS DURING THE MANUFACTURING PROCESS. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT A DEVICE FAILURE HAS OCCURRED; HOWEVER, THE SUPPLIER WAS NOT ABLE TO DETERMINE ROOT CAUSE. THE SUPPLIER HAS IMPLEMENTED ADDITIONAL PIECE COUNT CHECKS. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. REFER TO MDR 1226348-2017-10885 FOR INFORMATION REGARDING THE SECOND PRODUCT RECEIVED WITH THIS ONE.

    Additional Manufacturer Narrative · 1

    (B)(4). FOR P/C 801400- PATTIES:SAMPLES WERE NOT RETURNED THEREFORE EVALUATION TO CONFIRM MISCOUNT COULD NOT BE COMPLETED. A DHR REVIEW WAS COMPLETED AND NO ERRORS WERE FOUND. MANUFACTURING DOCUMENTATION WAS REVIEWED FOR ANY VARIATIONS IN CURRENT PROCESS AND NO VARIATIONS WERE FOUND. LOT NUMBER WAS SENT IN WITH THE SAMPLE (LOT NUMBER HA8252) FOR P/C 201037 RANEY CLIPS: THE MANUFACTURER WAS NOTIFIED OF THE COMPLAINT OF "MISCOUNT". THE PRODUCT WAS NOT RETURNED; THEREFORE, THE REPORTED " RANEY CLIP MISCOUNT" COULD NOT BE VERIFIED. DHR REVIEW FOR BOTH LOTS REPORTED AK605 AND DK653, THERE WERE NO MANUFACTURING DEFECTS NOTED DURING THE MANUFACTURING PROCESS. WE WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR COMPLAINTS FOR THESE PRODUCT CODES. AT THIS TIME TIS COMPLAINT IS CONSIDERED TO BE CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, A PACKAGE OF CODMAN PATTIES 10-PACK CONTAINED 11PATTIES, A CODMAN RAINEY CLIP 10-PACK CONTAINED 21 CLIPS AND ANOTHER CODMAN RAINEY CLIP 10-PACK CONTAINED 11 CLIPS. ONCE COUNT WAS DONE, HOSPITAL DISCARDED EXTRA PRODUCTS IN PACKAGES AND CONTINUED PROCEDURE. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839203 RANEY SCALP CLIPS CLIPS, SCALP HBO CODMAN & SHURTLEFF, INC. AK605

    Patients

    Seq Age Sex Outcome Treatment
    1