BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 2141582 · Received May 31, 2011

    Report

    Report Number
    1820334-2011-00268
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 5, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION: UNK AS LOT IS UNK. (B)(4): SEPARATION IS LABELED IN THE IFU. ONE USED MAC-LOC ASSEMBLY AND A PORTION OF THE DEVICE SHAFT WAS RETURNED. A GROOVE IS VISIBLE ON THE MOST PROXIMAL PORTION OF THE FLARE WHICH SUGGESTS THAT THE FLARE WAS CAUGHT IN THE THREADS OF THE CAP AND ADAPTER. QC INSPECTS TO CONFIRM THE CATHETER SHAFT IS SECURE IN PROXIMAL FITTINGS. INSTRUCTIONS FOR USE (IFU), PROVIDES INSTRUCTIONS FOR INSERTION AND REMOVAL AS WELL AS APPLICABLE WARNINGS AND PRECAUTIONS. WORK INSTRUCTIONS FOR FLARING, DESCRIBES THE FLARING PROCESS. ONE USED MAC-LOC ASSEMBLY AND A PORTION OF THE DEVICE SHAFT WAS RETURNED. A GROOVE IS VISIBLE ON THE MOST PROXIMAL PORTION OF THE FLARE ON THE SHAFT OF THE DEVICE WHICH SUGGESTS THAT THE FLARE WAS CAUGHT IN THE THREADS OF THE CAP AND ADAPTER. PER QUALITY SYS INSTRUCTIONS, THE FLARE SHOULD FIT OVER THE NOSE OF THE ADAPTER BUT NOT UP ONTO ADAPTER THREADS. THIS SUGGESTS THAT THE FLARE WAS SLIGHTLY OVERSIZED. QC VERIFIES THAT THE SHAFT IS SECURE IN THE PROXIMAL FITTINGS. IT IS FEASIBLE TO SUGGEST THAT THIS FAILURE IS OPERATOR RELATED. CAPA WAS PREVIOUSLY OPENED TO PREVENT THIS TYPE OF EVENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL. QUALITY ENGINEERING RISK ASSESSMENT (QERA) WAS NOT UPDATED IN RESPONSE TO THIS COMPLAINT AS THE INCLUSION OF THIS COMPLAINT WOULD NOT INCREASE THE OCCURRENCE RATE OR RISK PRIORITY NUMBER. THEREFORE, THE CONCLUSION OF THE QERA IS THAT NO FURTHER MITIGATING ACTION IS NECESSARY AT THIS TIME, IS STILL VALID.

    Description of Event or Problem · 1

    AS REPORTED TO COOK VIA TELEPHONE: THE CAREGIVER OBSERVED FLUID LEAKING ON PT BEDDING. THE PT HAD A TRANSCATH IN THE CHEST AREA. CARETAKER NOTICED THE CATHETER WAS SEPARATED AT THE HUB JUNCTION. NO HARM TO THE PT. FROM THE INFO PROVIDED BY THE REPORTER, NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK