BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 30IN 1 D/A XLH

    MDR report key: 11679425 · Received April 16, 2021

    Report

    Report Number
    2210968-2021-03453
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 23, 2021
    Report Date
    March 24, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031013209
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 5/25/2021. 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 H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION EVALUATION WAS CONDUCTED ON THE RETURNED DEVICE. THE PRODUCT CODE IS DOUBLE ARMED. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE OPENED SAMPLE OF PRODUCT CODE 8190 WAS RECEIVED FOR EVALUATION, THE NEEDLES WERE CUT FROM SUTURE AND THE SWAGE AND ATTACHMENT AREA OF TWO WERE NOTED TO BE AS EXPECTED, THE SUTURE WAS OBSERVED WITH DAMAGED ON THE SURFACE AND THE ENDS WERE CUT APPEARS TO BE BY USE OF THE SURGICAL INSTRUMENT. THE PRODUCT CODE 8190 CONTAINS ABSORBABLE SUTURE AND AS THE SAMPLE WAS RECEIVED OPEN, THE TIME OF EXPOSURE OF SUTURE TO THE ENVIRONMENT COULD NOT BE DETERMINED AND NO FUNCTIONAL TEST CAN BE PERFORMED DUE TO SAMPLE CONDITION. THE CONDITION OF THE SAMPLE RECEIVED INDICATES IMPROPER HANDLING OF THE DEVICE. THE MANUFACTURING RECORDS COULDN'T BE REVIEWED AS THE BATCH NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH BATCH IS RANDOMLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THE WHOLE SUTURE UNEVEN OR JUST A SEGMENT? JUST A SEGMENT. WAS THE SUTURE DIAMETER OTHER THAN EXPECTED? NO FURTHER INFORMATION IS AVAILABLE. WAS THE SUTURE USED ON THE PATIENT? NO FURTHER INFORMATION IS AVAILABLE. COULD YOU PLEASE PROVIDE THE LOT NUMBER? NO FURTHER INFORMATION IS AVAILABLE. PROCEDURE NAME? NO FURTHER INFORMATION IS AVAILABLE. 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 AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THERE HAD BEEN A PART WHERE THE SUTURE WAS LIKELY TO BREAK. THERE WAS A POSSIBILITY THAT THE THICKNESS OF THE SUTURE WAS UNEVEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576061 PRLNE BLU 30IN 1 D/A XLH SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 8190G 10705031013209

    Patients

    Seq Age Sex Outcome Treatment
    1