BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET: 19 GA

    MDR report key: 12372424 · Received August 26, 2021

    Report

    Report Number
    3006425876-2021-00811
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    August 17, 2021
    Report Date
    August 17, 2021
    Product Code
    BSO
    UDI-DI
    40801902128407
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LIDSTOCK WITH A POTENTIALLY RELEVANT FINDING. FOR MATERIAL # PBZ-05400-001A (UNPRINTED TYVEK), A NONCONFORMANCE WAS INITIATED BASED ON THE INVESTIGATION FROM THIS COMPLAINT. THE CUSTOMER REPORTED THE KIT WAS NOT COMPLETELY SEALED. THE CUSTOMER RETURNED ONE SEALED KIT. VISUAL EXAMINATION OF THE RETURNED KIT REVEALED THE BOTTOM PORTION OF THE TRAY APPEARS TO BE MISSING ADHESIVE. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. A NONCONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. THE REPORTED COMPLAINT OF THE KIT NOT BEING COMPLETELY SEALED WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. VISUAL EXAMINATION OF THE RETURNED KIT REVEALED THE BOTTOM PORTION OF THE TRAY APPEARED TO BE MISSING ADHESIVE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH A POTENTIALLY RELEVANT FINDING ON THE LIDSTOCK BASED ON THIS COMPLAINT INVESTIGATION. BASED ON THE TRAY MISSING ADHESIVE, THE POTENTIAL ROOT CAUSE OF THIS COMPLAINT ISSUE IS MANUFACTURING RELATED. A NONCONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    THE DOCTOR DID INVENTORY CHECK AND FOUND THAT THE PACKAGE OPENING WAS NOT COMPLETELY SEALED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE DOCTOR DID INVENTORY CHECK AND FOUND THAT THE PACKAGE OPENING WAS NOT COMPLETELY SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270934 EPIDURAL CATHETERIZATION SET: 19 GA ANESTHESIA CONDUCTION CATHETER BSO IPN046378 71F20F2476 40801902128407

    Patients

    Seq Age Sex Outcome Treatment
    1