BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN CATHETER

    MDR report key: 4729717 · Received April 21, 2015

    Report

    Report Number
    1000151187-2015-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    March 17, 2015
    Report Date
    April 17, 2015
    Manufacturer
    AMERICAN CATHETER CORP
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AMERICAN CATHETER CORP REQUESTED THAT THE UNSEALED UNITS BE RETURNED TO THE COMPANY FOR EVALUATION. (B)(4) REPLACEMENT UNITS WERE SHIPPED ON (B)(4) 2015. PER (B)(6), THE DEVICES WERE FOUND TO BE UNSEALED UPON OPENING THE EXTERIOR SHIPPING BOX. UPON INSPECTION, IT WAS OBVIOUS THE PRODUCT WAS NOT SEALED DURING THE MANUFACTURING PROCESS. AMERICAN CATHETER CORP HAS CHANGED ITS POLICIES/PROCEDURES TO INCLUDE A SEAL VERIFICATION PRIOR TO SHIPMENT TO THE USER FACILITY. AMERICAN CATHETER CORP DETERMINED THAT THIS EVENT DID NOT POSE AN UNREASONABLE RISK OF HARM TO THE PATIENT BECAUSE USER IS UNLIKELY TO USE DEVICE BECAUSE DEFECT IS HIGHLY DETECTABLE AND IT WOULD BE REASONABLE TO ASSUME THAT THE DEVICE IS CHECKED PRIOR TO USE IN THE OPERATING ROOM.

    Description of Event or Problem · 1

    AMERICAN CATHETER CORP. GENERAL MGR (B)(4) RECEIVED A CALL FROM (B)(6) STATING HE HAD RECEIVED 20 UNITS OF THE AMERICAN CATHETER 9100 (LOT 14101601) AND OF THOSE 20 UNITS, 11 WERE NOT SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263369 AMERICAN CATHETER LAPAROSCOPIC CHOLANGIOGRAM CATHETER GBZ AMERICAN CATHETER CORP 9100 14101601

    Patients

    Seq Age Sex Outcome Treatment
    1