BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 4X30IN 7-0 D/A BV175-6 MP

    MDR report key: 10773805 · Received November 2, 2020

    Report

    Report Number
    2210968-2020-08567
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 21, 2020
    Report Date
    October 21, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031045958
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 12/15/2020. ADDITIONAL H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH QABAAE, M873119 AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IT WAS REPORTED "THE NEEDLE POPPED OFF THE STRING." PLEASE CLARIFY: WHAT DOES " NEEDLE POPPED OFF THE STRING" MEAN? IS IT NEEDLE DETACHED FROM THE SUTURE DURING THE PROCEDURE? WAS THE NEEDLE REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE? WAS THERE ANY PATIENT CONSEQUENCE OR INJURY? PROCEDURE DATE? 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 CARDIOVASCULAR PROCEDURE ON (B)(6) 2020; AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233668 PRLNE BLU 4X30IN 7-0 D/A BV175-6 MP SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. M8731 QABAAE 10705031045958

    Patients

    Seq Age Sex Outcome Treatment
    1