BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON ABSORBABLE SURGICAL SUTURE

    MDR report key: 13874876 · Received March 24, 2022

    Report

    Report Number
    2210968-2022-02122
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    August 17, 2021
    Report Date
    March 23, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. PHOTO ANALYSIS: FOLLOWING IS THE DETAIL OF THE EVALUATION PERFORMED DURING INVESTIGATION. VISUAL COMPARISON OF COMPLAINT SAMPLE PHOTOGRAPH WITH RETAIN SAMPLE: RECEIVED COMPLAINT SAMPLE PHOTOGRAPH WAS VISUALLY INSPECTED AND COMPARED WITH RETAIN SAMPLE OF PRODUCT CODE NW844 AND LOT B6023. UPON VISUAL INSPECTION IT HAS BEEN OBSERVED THAT THE PRODUCT PACKING WAS NOT MATCHING WITH RETAINED SAMPLE. ACTUAL PRODUCT PACKAGING COMPRISES OF SWAGES SUTURE NEEDLE PARKED AND WOUND IN (B)(4) TRAY WITH (B)(4) LID PACKED IN TRANSPARENT OVERWRAP WITH WHITE BOTTOM. WHERE IN COMPLAINT SAMPLE PHOTOGRAPH PRODUCT WAS LABELED AND PACKED IN SINGLE BARRIER FOLDER WHICH CLEARLY DIFFERENTIATE THE PRODUCT. IN ADDITION, 2D BARCODE SCANNING WAS PERFORMED OVER SINGLE BARRIER FOLDER AND NON-COMPLIANT RESULTS WERE OBSERVED. BARCODE SCANNING DETAILS: BARCODE. COMPLAINT SAMPLE SBF: (B)(4). RETAIN SAMPLE SBF: (B)(4). CONCLUSION: COMPLAINT SAMPLE PHOTOGRAPH AND RETAIN SAMPLE COMPARISON INCLUDING VISUAL INSPECTION REVEALED THAT COMPLAINT SAMPLE IS NOT A GENUINE PRODUCT MANUFACTURED AT ETHICON (B)(4) SITE. THIS COMPLAINT IS CONCLUDED AS ¿CONFIRM COUNTERFEIT PRODUCT¿. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE CONFIRM IF THE VENDOR IS AUTHORIZED BY (B)(6)? COVERT MARKET SURVEY ACTIVITY WAS UNDERTAKEN AT CHEMIST/ PHARMACIST/ SURGICAL STORES WHICH WERE CONDUCTED BY (B)(6). COULD YOU PLEASE PROVIDE THE ATTACHMENTS FOR THE PRODUCTS TRACEABILITY INFORMATION FROM (B)(4)? THESE ARE LOCALLY MANUFACTURED PRODUCTS IN (B)(4) HENCE NOT APPLICABLE. HOW WAS THE PRODUCT PURCHASED? ON NO NAMES BASIS DURING COVERT MARKET SURVEY. IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? STILL BEING EVALUATED (WIP). IS THERE ANY INDICATION OF THE SOURCE? STILL BEING EVALUATED (WIP). WAS THE DEVICE USED ON A PATIENT? IF SO, WAS THERE ANY PATIENT CONSEQUENCE? NO. DEVICE RETURN STATUS: PHOTOGRAPH AVAILABLE. DEVICE AVAILABLE WITH EXTERNAL TEAM. ATTEMPTS HAVE BEEN 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 BEFORE USE ON THE PATIENT, A COVERT MARKET SURVEY WAS CONDUCTED. DURING THE MARKET SURVEY, A COUNTERFEIT PRODUCT WAS IDENTIFIED IN A RETAIL STORE AT (B)(6). FOLLOWING IS THE DETAIL OF THE EVALUATION PERFORMED DURING INVESTIGATION. VISUAL COMPARISON OF COMPLAINT SAMPLE PHOTOGRAPH WITH RETAINED SAMPLE: RECEIVED COMPLAINT SAMPLE PHOTOGRAPH WAS VISUALLY INSPECTED AND COMPARED WITH RETAIN SAMPLE OF PRODUCT CODE NW844 AND LOT B6023. UPON VISUAL INSPECTION IT HAS BEEN OBSERVED THAT THE PRODUCT PACKING WAS NOT MATCHING WITH RETAINED SAMPLE. ACTUAL PRODUCT PACKAGING COMPRISES OF SWAGES SUTURE NEEDLE PARKED AND WOUND IN ZIPPER TRAY WITH ZIPPER LID PACKED IN TRANSPARENT OVERWRAP WITH WHITE BOTTOM. WHERE IN COMPLAINT SAMPLE PHOTOGRAPH PRODUCT WAS LABELED AND PACKED IN SINGLE BARRIER FOLDER WHICH CLEARLY DIFFERENTIATE THE PRODUCT. IN ADDITION, 2D BARCODE SCANNING WAS PERFORMED OVER SINGLE BARRIER FOLDER AND NON-COMPLIANT RESULTS WERE OBSERVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728131 NON ABSORBABLE SURGICAL SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. B6023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown