BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAMEY MALECOT SUPRAPUBIC CATHETER SET

    MDR report key: 4143409 · Received September 12, 2014

    Report

    Report Number
    1820334-2014-00434
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 18, 2014
    Manufacturer
    COOK, INC.
    Product Code
    KOB
    PMA / PMN Number
    K780765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL (QC) AND TRENDS WAS CONDUCTED. PART NUMBER IS NOT GIVEN IN THE COMPLAINT DESCRIPTION. HOWEVER, WE INFER THAT IT REFERS TO THE 0838XX FAMILY OF SILICONE MALECOT CATHETERS, AS THEY ARE THE ONLY ONES THAT FIT THE DESCRIPTION. MATERIAL AND TENSILS STRENGTH ARE VERIFIED BY THE SUPPLIER, AND SHOWN ON THE CERTIFICATE OF COMPLIANCE. IN ADDITION, COMPONENT SPECIFICATION 0838XX STATES "CHECK TO BE FREE OF DEBRIS, DISCOLORATION, FLAKING OR PEELING" AT A 100% INSPECTION. WITHOUT EVALUATING THE ACTUAL PRODUCT, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THIS FAILURE. APPROPRIATE CONTROLS ARE IN PLACE TO DETECT ANY POTENTIAL FAILURE POINT IN THE TIP OF THE CATHETER. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL. PER THE QUALITY ENGINEERING RISK ASSESSMENT (QERA), NO ADDITIONAL ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT IS A (B)(6) MALE WITH A HISTORY OF RECENT BLADDER NECK RECONSTRUCTION ON (B)(6) 2014. HE WAS ADMITTED ON (B)(6) 2014 FOR ENDOSCOPIC EVALUATION. HE HAD SOME LEAKAGE FROM HIS MIDLINE INCISION. HE WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2014 FOR REMOVAL OF ALL TUBES AND DRAINS THAT WERE PLACED ON (B)(6). WITH THE 12 FRENCH MALECOT CATHETER WAS REMOVED, THE TIP WAS MISSING. A CYSTOSCOPY WAS DONE AND THE MISSING TIP WAS NOT IN THE BLADDER. A SMALL INCISION WAS MADE AND AN EXPLORATORY LAP WAS PERFORMED TO LOOK FOR THE TIP BETWEEN THE BLADDER AND ABDOMINAL WALL. IT COULD NOT BE LOCATED. AN X-RAY WAS ALSO TAKEN WHICH DID NOT SHOW THE MISSING TIP. IT IS NOT RADIOPAQUE. IT IS UNKNOWN IF A SECTION OF THE DEVICE REMAINS INSIDE THE PATIENT. IT COULD NOT BE LOCATED. THE PATIENT HAS REQUIRED A CYSTOSCOPY, AN EXPLORATORY LAP AND AN X-RAY DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565244 STAMEY MALECOT SUPRAPUBIC CATHETER SET KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) KOB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention