BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 24IN 8-0 D/A BV130-5 EP

    MDR report key: 18234999 · Received November 29, 2023

    Report

    Report Number
    2210968-2023-09305
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    January 1, 2023
    Report Date
    November 29, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031215948
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. 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: WHEN WAS THE NEEDLE DETACHED/PULLED OFF FROM THE SUTURE (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING PRIOR TO USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY DURING CORONARY ANASTOMOSIS. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-SUTURING; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY. NO. HOW LONG (IN MINUTES) DID THE SURGERY PROLONG? 15 MIN. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? NO. WHAT TISSUE WAS BEING SUTURED WHEN THE EVENT OCCURRED? CORONARY ARTERY. WAS ADDITIONAL DISSECTION REQUIRED IN OTHER ORGANS/TISSUES OTHER THAN THE TARGET TISSUE? NO. WAS THERE ANY CHANGE IN THE PATIENT¿S POST OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? NO. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. RELATED MEDWATCH REPORTS: 2210968-2023-09303, 2210968-2023-09304, 2210968-2023-09305, 2210968-2023-09306.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BYPASS ANASTOMOSIS ON AN UNKNOWN DATE AND SUTURE WAS USED. THE THREAD PULLED OFF THE NEEDLE DURING CORONARY ANASTOMOSIS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044664 PRLNE BLU 24IN 8-0 D/A BV130-5 EP SUTURES - NON-ABSORBABLE GAW ETHICON INC. RBBDSB 10705031215948

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown