BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 7065030 · Received November 28, 2017

    Report

    Report Number
    1820334-2017-04199
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    November 1, 2017
    Report Date
    March 23, 2018
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002095014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) # :EXEMPT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE (IFU), DOCUMENTATION, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS RETURNED. MEASUREMENTS OF THE COMPONENT IN QUESTION WERE PERFORMED, AND WE FOUND THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE REPORTED FAILURE COULD NOT BE OBSERVED OR DUPLICATED. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS PERFORMED, AND WE COULD NOT IDENTIFY A PUNCTURE ANYWHERE ON THE DEVICE. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE DEVICE HISTORY RECORD FOR LOT NUMBER 8153307 WAS REVIEWED. NO RELATED NON-CONFORMANCES WERE IDENTIFIED. A SEARCH OF OUR COMPLAINT RECORDS INDICATES THAT THIS IS THE ONLY COMPLAINT ON THE LOT NUMBER AT THE TIME OF INVESTIGATION. THE COMPLAINT WILL NOT BE CONFIRMED. BASED ON THE PROVIDED INFORMATION, INSPECTION OF RETURNED PRODUCT AND THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED OR REPORTED AT THIS TIME. THE PRODUCT PASSED VISUAL/DIMENSIONAL VERIFICATION. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WIRE OF THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER PUNCTURED THE DRAIN PORTION OF THE DEVICE. THE PROCEDURE WAS BEGUN AGAIN, USING A NEW CATHETER. ACCORDING TO THE CUSTOMER, NO PATIENT ADVERSE EVENTS OR ADDITIONAL PROCEDURES WERE NECESSITATED BY THE FAILURE OF THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NONE WAS PROVIDED BY THE REPORTER. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844349 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A 00827002095014

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR