BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS PLUS VIO 8X18IN 0 S/A CTB-1 CR

    MDR report key: 12656705 · Received October 19, 2021

    Report

    Report Number
    2210968-2021-09898
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 21, 2021
    Report Date
    November 18, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031218840
    PMA / PMN Number
    K061037
    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: 11/18/2021. H3 INVESTIGATIONAL NARRATIVE: THE PRODUCT WAS RETURNED TO ETHICON INC FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT THREE OPENED SAMPLES PRODUCT CODE PDPB740D WERE RECEIVED FOR EVALUATION. THE STRANDS WERE OBSERVED BROKEN DUE TO DEGRADATION PROCESS CAUSED BY EXPOSURE TO ENVIRONMENT. THE PRODUCT CODE PDPB740D CONTAINS AN ABSORBABLE SUTURE. AS THE PACKAGE WAS RECEIVED OPEN, THE TIME OF EXPOSED TO THE ENVIRONMENT COULD NOT BE DETERMINED AND FUNCTIONAL TEST CANNOT BE PERFORMED. THE FOILS WERE VISUALLY INSPECTED, AND NO HOLES WERE OBSERVED IN THE CAVITY. 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 COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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 · 0

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: * COULD YOU PLEASE CLARIFY THIS "" IT WAS APPARENTLY THINNER THAN OTHER PACKAGES"" DID YOU REFER TO THE PACKAGE OR THE SUTURE? PLEASE CLARIFY =>THE SUTURE. * COULD YOU PLEASE CONFIRM IF TWO SUTURES WERE BROKEN? PLEASE CLARIFY =>THE SUTURE WHICH WAS BROKEN DURING USE IS ONE. THE 2ND SUTURE WAS APPARENTLY THINNER THAN OTHER SUTURES, SO IT WAS NOT USED. * DID THE SURGERY WAS COMPLETED SUCCESSFULLY? =>NO FURTHER INFORMATION IS AVAILABLE. IF YES * WHAT WAS USED TO COMPLETE THE PROCEDURE? =>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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555618 PDS PLUS VIO 8X18IN 0 S/A CTB-1 CR SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. RAMMU 10705031218840

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown