BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON ABSORBABLE SURGICAL SUTURE

    MDR report key: 13637573 · Received March 1, 2022

    Report

    Report Number
    2210968-2022-01408
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    December 9, 2021
    Report Date
    March 4, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 3/4/2022. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. H3 INVESTIGATIONAL SUMMARY: COMPLAINT SAMPLE: 01 OPENED UNIT OF COMPLAINT SAMPLE RECEIVED FOR INVESTIGATION; THE COMPLAINT SAMPLE CONSIST OF ONE OPEN SBF FOLDER, DISCOLORED HARDENED SUTURE AND NEEDLE FOR CODE NW3348 LOT B9018. AS THE COMPLAINT SAMPLE RECEIVED IN OPEN CONDITION FURTHER INVESTIGATION WAS NOT PERFORMED ON COMPLAINT SAMPLE EXCEPT VISUAL INSPECTION. RECEIVED SUTURE WAS VISUALLY INSPECTED AND IT HAS BEEN IDENTIFIED THAT SUTURE SURFACE WAS HARD AND NON-SHINY WHICH INDICATED THAT SUTURE MIGHT BE RE-STERILIZED OR STORED INADEQUATELY ABOVE TEMPERATURE MAINTAINING CONDITION. DUE TO THE EXCEEDING TEMPERATURE MAINTAINING CONDITION OR APPLICATION OF SURFACE DISINFECTANT BEFORE USE MIGHT HAVE CONTRIBUTED THE EVENT. RECEIVED NEEDLE WAS VISUALLY INSPECTED AND FOUND SATISFACTORY. COMPLAINT SAMPLE FOIL WAS NOT RECEIVED FOR INVESTIGATION. RECEIVED EMPTY FOLDER WAS INSPECTED AND CHECKED AGAINST APPROVED ARTWORK AND FOUND TO BE GENUINE ETHICON INDIA MANUFACTURED ONE. COMPLAINT SAMPLE FOIL WAS NOT RECEIVED FOR INVESTIGATION. MANUFACTURING RECORDS REVIEW: AS A PART OF INVESTIGATION BATCH MANUFACTURING RECORD WAS REVIEWED. THE BATCH MANUFACTURING RECORD WAS REVIEWED FOR ANY PROCESS DEVIATION, BUT NO DEVIATION WAS OBSERVED. FINISHED GOODS RECORD WAS REVIEWED FOR FG RELEASE PARAMETERS LIKE DIAMETER, TENSILE STRENGTH VALUE, NEEDLE PULL-OFF VALUE & EXTRACTABLE COLOR AT RELEASE AND WAS FOUND TO MEET THE SPECIFICATION. FROM THE ABOVE ANALYSIS IT IS EVIDENT THAT THERE WAS NO ISSUE RELATED TO THE SUTURE QUALITY AND PROCESSING OF THIS INCIDENT LOT. RETAIN SAMPLE: FIVE RETAIN SAMPLES OF THE INCIDENT CODE NW3348 AND LOT NUMBER B9018 WERE RETRIEVED FOR ANALYSIS. THESE PACKS OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR ATTRIBUTE DEFECTS LIKE PSEUDO SEAL, PIN HOLE, PRODUCT IN SEAL, PRESS MARKS ON PACK BUT NO SUCH DEFECTS WERE OBSERVED. THESE PACKS WERE OPENED, AND SUTURES AND NEEDLES WERE FOUND INTACT. THE SUTURES WERE PHYSICALLY INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE KINKS, WEAK SPOTS, BROKEN PIECE, FRAY, BRITTLENESS, DETACHED NEEDLES, DISCOLORATION OF SUTURE BUT NO SUCH DEFECTS WERE OBSERVED. THE NEEDLES WERE INSPECTED FOR ANY ATTRIBUTE DEFECTS LIKE BEND, CRACKED BARREL, FINS BUT NO SUCH DEFECTS WERE OBSERVED. AS COMPLAINT DESCRIPTION IS RELATED TO PERFORMANCE-PULL OFF SUTURE NEEDLE/APPEARANCE-COSMETIC OR COLOR - SUTURE, NEEDLE PULL TEST AS WELL AS EXTRACTABLE COLOR TEST IS APPLICABLE & MEASURABLE PARAMETER. NEEDLE PULL-OFF TEST WAS PERFORMED OVER FIVE RETAIN SAMPLES TO CHECK THE BEHAVIOR OF THE SWAGING PROCESS. THE AVERAGE NEEDLE PULL VALUE OF THE RETAIN SAMPLE WAS FOUND TO BE 3.899 KGF AND VALUE AT RELEASE WAS FOUND TO BE 3.490 KGF WHICH MEETS THE AVERAGE IN-HOUSE REQUIREMENT I.E. NLT 1.800 KGF. EXTRACTABLE COLOR TEST WAS PERFORMED OVER RETAIN SAMPLES AND COMPLIANT RESULTS WERE OBTAINED. ALL THE INDIVIDUAL NEEDLE PULL TEST VALUES FOR RETAIN SAMPLE AS WELL AS EXTRACTABLE COLOR TEST RESULT WERE FOUND TO BE MEETING SPECIFICATION REQUIREMENT. THIS ANALYSIS SHOWS THAT THERE WAS NO ISSUE RELATED TO PROCESSING OF THE LOT. ALL THE VALUES ARE WITHIN THE CONTROL LIMITS. BASED ON THE ANALYSIS THIS IS NOT A CONFIRMED COMPLAINT. THE REPORTED INCIDENT IS ONE AND ISOLATED CASE FOR CODE NW3348 LOT B9018. NO OTHER EVENT WAS REPORTED FOR SAME DESCRIPTION FROM OTHER PARTS OF COUNTRY WHERE THIS LOT WAS DISTRIBUTED. BASED ON THE ANALYSIS THIS IS NOT A CONFIRMED COMPLAINT. CONSIDERING ABOVE INVESTIGATION ADEQUATE TO ADDRESS THE REPORTED COMPLAINT, THIS COMPLAINT IS RECOMMENDED FOR CLOSURE APPROVAL. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN LAPAROTOMY PROCEDURE ON (B)(6) 2021. AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED AT THE SWAGE PART. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302925 NON ABSORBABLE SURGICAL SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. B9018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown