BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10086570 · Received May 26, 2020

    Report

    Report Number
    2210968-2020-04097
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 14, 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

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT TO THE FDA: 7/7/2020 ADDITIONAL INFORMATION: D4, H4, H6 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH PKB748, M873119 AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (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. 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. COULD YOU PLEASE CONFIRM IF THE ISSUE OCCURRED WITH THE SUTURE OR WITH THE NEEDLE? DEVICE RETURN FOLLOW UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOTOMY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE KEPT BREAKING. SWITCHED TO ANOTHER LOT TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551669 PRLNE BLU 4X30IN 7-0 D/A BV175-6 MP SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. M8731 PKB748 10705031045958

    Patients

    Seq Age Sex Outcome Treatment
    1