BEUDAMED
    FDA Adverse Event Summary report: N

    LAP SPONGES

    MDR report key: 5188969 · Received October 29, 2015

    Report

    Report Number
    2320762-2015-00020
    Date Received
    October 29, 2015
    Date of Event
    July 30, 2015
    Report Date
    October 29, 2015
    Manufacturer
    JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD.
    Product Code
    GDY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: (B)(4) SUPPLIES PART NUMBER 1-1818 TO DEROYAL. IN ITS SUPPLIER CORRECTIVE ACTION RESPONSE (SCAR), (B)(4) CONCLUDED THE ROOT CAUSE WAS A MANUFACTURING ERROR. ALL SPONGE PACKS ARE REQUIRED TO GO THROUGH A WEIGHING PROCEDURE TO CONFIRM CORRECT PIECE COUNT. ONE OF THE OPERATORS REMOVED THE SPONGE PACK FROM THE SCALE BEFORE THE CORRECT WEIGHT WAS READ, WHICH RESULTED IN A MISCOUNT. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: THE SUPPLIER HAS INDICATED AN AUTOMATIC WEIGHT MACHINE WAS INSTALLED IN THE BEGINNING OF 2015 FOR THE COUNTING PROCEDURE. IF THE WEIGHT OF ANY PACK OF LAP SPONGES DEVIATES FROM THE REQUIRED PARAMETER, THE PACK IS AUTOMATICALLY REMOVED TO THE REJECTION BIN. THE DEFECTIVE LAP SPONGE PACK ASSOCIATED WITH THIS REPORT WAS MANUFACTURED IN MARCH 2014 BEFORE THE AUTOMATIC WEIGHT MACHINE WAS IMPLEMENTED. REFER TO THE ATTACHED PHOTOS OF THE AUTOMATIC WEIGHT MACHINE. INVESTIGATION SUMMARY: A COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT A PACK OF LAPAROTOMY SPONGES (PART NUMBER 1-1818, LOT NUMBER 1040303) CONTAINED FOUR SPONGES INSTEAD OF FIVE. THE RAW MATERIAL IS SUPPLIED BY (B)(4). THE QC COMPLAINT SPECIALIST REVIEWED THE 2013-2015 SCAR AND SUPPLIER NOTIFICATION LETTER (SNL) LOGS FOR SIMILAR COMPLAINTS. NO SIMILAR COMPLAINTS WERE IDENTIFIED FOR PART NUMBER 1-1818. HOWEVER, SIMILAR COMPLAINTS OF MISCOUNTS WERE IDENTIFIED IN ASSOCIATION WITH THE PRODUCT LINE. THEREFORE, A SCAR WAS ISSUED TO (B)(4) AND A RESPONSE RECEIVED ON 10/15/2015. IN ITS RESPONSE, (B)(4) IDENTIFIED THE RAW MATERIAL WAS PRODUCED PRIOR TO THE IMPLEMENTATION OF AN AUTOMATIC WEIGHT COUNTING MACHINE. THE QC COMPLAINT SPECIALIST REVIEWED THE QUALITY FEEDBACK INVESTIGATION REPORT FOR SALES AND SIMILAR COMPLAINT INFORMATION. (B)(4). THERE HAVE BEEN NO PREVIOUS REPORTS OF MISCOUNTS REPORTED FOR PART NUMBER 1-1818. PREVENTIVE ACTION: IN ITS SCAR RESPONSE, (B)(4) STATED THE AUTOMATIC COUNTING MACHINE HAS BEEN INSTALLED TO PREVENT ANY MISCOUNT. THIS INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED. (B)(4).

    Description of Event or Problem · 1

    THE PACKAGE OF LAP SPONGES ONLY CONTAINED 4 SPONGES INSTEAD OF 5. THE SPONGES AND PACKAGE WERE SAVED AND GIVEN TO THE CLINICAL EDUCATOR TO FORWARD TO MATERIALS MANAGEMENT. THE ORIGINAL INTENDED PROCEDURE WAS AN EXPLORATION OF L GROIN; REPAIR OF STRANGULATED L FEMORAL HERNIA; LAPARATOMY; RESECTION OF SMALL INTESTINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718790 LAP SPONGES GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD. 1040303

    Patients

    Seq Age Sex Outcome Treatment
    1