BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEEL SUTURE 18"(45CM) 6 B&S

    MDR report key: 7241128 · Received February 5, 2018

    Report

    Report Number
    2210968-2018-70657
    Event Type
    Malfunction
    Date Received
    February 5, 2018
    Date of Event
    January 11, 2018
    Report Date
    January 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    UDI-DI
    10705031045415
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 02/20/2018 ADDITIONAL INFORMATION ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH LGP466 MFG DATE: 6/10/2017, EXP DATE: 5/31/2022 IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THE PRODUCT 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.

    Additional Manufacturer Narrative · 1

    PC-(B)(4). AN EMPTY OPENED FOLDER, A DETACHED NEEDLE AND A SUTURE WERE RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF DETACHED NEEDLE, THE SWAGE AND ATTACHMENT AREA WERE NOT AS EXPECTED, SINCE THE SWAGE AREA IS SHORTER THAN THE DIE LENGTH THIS CONDITION CAUSES THAT THE NEEDLE WAS DETACHED OF THE SUTURE. PER THE SAMPLE CONDITION THE ASSIGNABLE CAUSE OF PERFORMANCE PULL OFF SUTURE NEEDLE IS AN INCORRECT SWAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH LGP466, MFG DATE: UNK, EXP DATE: UNK. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE WIRE WHEN TAKING OUT THE WIRE USING FORCEPS WHILE CLOSING THE SURGICAL WOUND ON THE CHEST. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86219 STEEL SUTURE 18"(45CM) 6 B&S SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. UNK 10705031045415

    Patients

    Seq Age Sex Outcome Treatment
    1