BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROPASS AS 11/13FR X 54 CM 5/BX

    MDR report key: 10108823 · Received June 2, 2020

    Report

    Report Number
    3003790304-2020-00023
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Report Date
    August 27, 2020
    Manufacturer
    TELEFLEX MEDICAL OEM
    Product Code
    KNY
    PMA / PMN Number
    K051593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS INTENDED TO PROVIDE THE RESULTS OF THE DEVICE EVALUATION, INVESTIGATION AND DEVICE HISTORY RECORD (DHR) REVIEW. THE SUSPECT DEVICE WAS RETURNED TO OLYMPUS AND EVALUATED. THE REPORTED PROBLEM OF "DEBRIS ON DISTAL TIP IN THE SEALED PACKAGE" WAS CONFIRMED. UPON EVALUATION, IT WAS NOTED THAT A FOREIGN OBJECT OR DEBRIS (FOD) WAS PRESENT INSIDE OF THE DEVICE. THE DEVICE REMAINED IN THE SEALED, STERILE, TYVEK POUCH THAT IT WAS ORIGINALLY PACKAGED IN. THE TYVEK PACKAGING WAS INSPECTED AND DID NOT APPEAR TO HAVE ANY PUNCTURES ANYWHERE IN THE PACKAGING. THE FOD IS LOCATED ON THE DISTAL END, INSIDE THE TIP OF THE DEVICE. THE FOREIGN MATERIAL APPEARS TO HAVE A RED-ISH HUE. A DHR REVIEW WAS COMPLETED BY THE SUPPLIER AND IT WAS NOTED THAT THERE WERE NO ABNORMALITIES. THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) ALSO PERFORMED A DHR REVIEW ON INCOMING INSPECTION AND ASSEMBLY PROCESS WITH NO ABNORMALITIES RELATING TO THE FOD. THE SUSPECT DEVICE WAS TESTED BY A 3RD PARTY LABORATORY. THE LABORATORY CONFIRMED THAT THE FOREIGN MATERIAL IS NOT OF BIOLOGICAL ORIGIN, HOWEVER, THE COMPOSITION OF THE FOREIGN MATERIAL COULD NOT BE DETERMINED. A ROOT CAUSE FOR THE THE REPORTED PROBLEM COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION HAS NOT BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, THE RESULTS WILL BE SUBMITTED ON A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A USER FACILITY RETURNED AN UNUSED UNOPENED UROPASS AS 11/13 FR X 54 CM 5/BX, MODEL 61154BX, DEVICE TO OLYMPUS. THERE WAS NOTED TO BE DEBRIS ON THE DISTAL TIP IN THE SEALED PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574503 UROPASS AS 11/13FR X 54 CM 5/BX URETERAL ACCESS SHEATH KNY TELEFLEX MEDICAL OEM 61154BX 09G1500285

    Patients

    Seq Age Sex Outcome Treatment
    1