BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 8X18IN 0 S/A CTB-1 CR

    MDR report key: 12586039 · Received October 6, 2021

    Report

    Report Number
    2210968-2021-09282
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 8, 2021
    Report Date
    September 9, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031044029
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/11/2021. H6 COMPONENT CODE: G07002 - CAUSE NOT ESTABLISHED. 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: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION EVALUATION WAS CONDUCTED ON THE RETURNED DEVICE. A PAPER LID AND A WINDING FORMER WITH EIGHT DETACHED NEEDLES OF PRODUCT CODE JB840 WERE RECEIVED FOR ANALYSIS. THE PRODUCT CODE IS CONTROL RELEASE AND REQUIRED EIGHT STRANDS PER PACKET IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THE SWAGE AREA OF THE NEEDLE WAS NOTED WITH MARKS THAT APPEARS TO BE BY SURGICAL INSTRUMENT. THE SUTURE WAS NOT RECEIVED FOR EVALUATION TO DETERMINE THE ASSIGNABLE CAUSE. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE REPORTED COMPLAINT. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, THE DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Additional Manufacturer Narrative · 0

    (B)(4). 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: QTY OF PRODUCT INVOLVED: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. EVENTS REPORTED IN 2210968-2021-09283.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481332 VCL CT BRD UD 8X18IN 0 S/A CTB-1 CR SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. JB840 RAMLLU 10705031044029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown