BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON ABSORBABLE SURGICAL SUTURE

    MDR report key: 13119445 · Received December 30, 2021

    Report

    Report Number
    2210968-2021-13081
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 9, 2021
    Report Date
    March 1, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 03/01/2022. H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. 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. H3 INVESTIGATION SUMMARY: 1 OPENED UNIT OF COMPLAINT SAMPLE RECEIVED FOR INVESTIGATION; THE COMPLAINT SAMPLE CONSIST OF ONE OPEN SBF FOLDER ONLY FOR CODE NW3348 LOT B8002. IMPACTED SUTURE AND NEEDLE WAS NOT RECEIVED FOR INVESTIGATION. IN ABSENCE OF COMPLETE DEVICE FOR INVESTIGATION IT CANNOT BE CONCLUDED AS WHAT MIGHT HAVE CONTRIBUTED THE EVENT. 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 B8002 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 4.783 KGF AND VALUE AT RELEASE WAS FOUND TO BE 3.613 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 B8002. 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. 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). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    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
    2017241 NON ABSORBABLE SURGICAL SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. B8002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown