BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 3222055 · Received July 5, 2013

    Report

    Report Number
    1820334-2013-00285
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 21, 2013
    Manufacturer
    COOK INC
    Product Code
    GBO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNK AS LOT IS UNK. ONE USED AND SEPARATE DEVICE WAS RETURNED. THE CATHETER SHAFT WAS PULLED FROM THE CAP/ADAPTER. INSPECTION OF THE PROXIMAL END OF THE RETURNED CATHETER SHAFT SHOWED THREAD MARKS VISIBLE IN THE FLARE OF THE DEVICE WHICH SUGGESTS THAT THE FLARE WAS OVERSIZED. QUALITY CONTROL CONFIRMS THAT THE CATHETER SHAFT IS SECURE IN THE PROXIMAL FITTINGS. ADDITIONALLY, INSTRUCTIONS FOR USE (IFU) PROVIDES INSTRUCTIONS FOR INSERTION AND REMOVAL AS WELL AS APPLICABLE WARNINGS AND PRECAUTIONS. BASED UPON THE EXAMINATION OF THE RETURNED DEVICE, THE FLARE WAS OVERSIZED. THE OVERSIZING OF THE FLARE HAS CAUSED THE MATERIAL TO THIN AND MAY HAVE LED TO THE SEPARATION OF THE PROXIMAL FITTINGS FROM THE DEVICE ONCE ENOUGH TENSILE FORCE WAS APPLIED TO THE FITTING. THE CATHETER WAS REMOVED AND REPLACED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL. PER THE CONCLUSION OF QUALITY ENGINEERING RISK ASSESSMENT (QERA), NO RISK MITIGATING ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) MALE WITH PLEURAL EFFUSION, UNDERWENT A PCD PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE AT THE IR SUITES, THERE WAS NO PROBLEM. HOWEVER, EIGHT DAYS AFTER DRAINAGE INSERTION ((B)(6) 2013), THE PT'S GOWN WAS CONTAMINATED BY BLOOD OOZING AND THE PT COMPLAINED ABOUT IT. THE NURSE FOUND OUT THE BREAKAGE CATH. THE BREAKAGE CATH WAS IMMEDIATELY REMOVED BY HAND AND REPLACED WITH A NEW ONE. AFTER CHECKING THE PT'S CONDITION, THE DOCTOR DETERMINED THE PCD WAS NOT NEEDED BY THE PT ANY MORE, SO IT WAS REMOVED. PT OUTCOME WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307131 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR