BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE MULTIPURPOSE DRAINAGE SET

    MDR report key: 3964151 · Received July 11, 2014

    Report

    Report Number
    1820334-2014-00296
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE DEVICE IS INSPECTED BY QUAL CONTROL FOR SUTURE SECURITY AT BOTH THE PROXIMAL AND DISTAL ENDS, AND INSPECTS FUNCTIONALITY. QUAL CONTROL ENSURES THAT THE CURVE IS ABLE TO BE OPENED AND CLOSED. THE DEVICE IS SUPPLIED WITH INSTRUCTIONS FOR USE WHICH LISTS THE FOLLOWING STEPS FOR CATHETER EXCHANGE/REMOVAL: "WHILE STABILIZING THE MAC-LOC CATHETER HUB ASSEMBLY WITH ONE HAND, POSITION A SMALL, BLUNT OBJECT (APPROXIMATELY THE SHAPE AND SIZE OF A BALL POINT PEN OR SMALL FORCEPS) INTO THE MAC-LOC RELEASE NOTCH. PRY UPWARD UNTIL THE LOCKING CAM LEVER IS FREE." IF THE PIGTAIL WAS NOT LOCKED IN A FULLY CLOSED POSITION, THIS MAY LEAVE A SEGMENT OF THE LOCKING SUTURE EXPOSED IN THE TISSUE. THIS EXPOSED SUTURE MAY DEVELOP ENCRUSTATION, MAKING IT DIFFICULT TO RELEASE THE PIGTAIL AND/OR REMOVE THE DEVICE. WITHOUT RETURN OF THE COMPLAINT DEVICE OR PROVIDED IMAGES, A DEFINITIVE ROOT CAUSE FOR THIS FAILURE CANNOT BE DETERMINED. THE SEPARATED SUTURE REMAINS IN THE PT AND WILL BE MONITORED. WE HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE CONCLUSION OF QUAL ENGINEERING RISK ASSESSMENT, MITIGATING ACTION IS NOT REQUIRED.

    Description of Event or Problem · 1

    AROUND (B)(6) 2014, A PT WITH RECTAL CANCER UNDERWENT PERCUTANEOUS PELVIC SUPPURATION DRAINAGE. AFTER THE MAC-LOC WAS UNLOCKED, THE ATTEMPT TO WITHDRAW THE DEVICE OUT OF THE BODY WAS PERFORMED. HOWEVER, AS THE SUTURE OF THE CATHETER WAS STUCK ON SOMEWHERE IN THE BODY, IT COULD NOT BE RETRIEVED. AFTER CUTTING THE CATHETER AND THE SUTURE, THE PHYSICIAN RETRIED THE WITHDRAWAL, BUT THE SUTURE WAS STILL ADHERED TO SOMEWHERE IN THE BODY AND THUS, ONLY THE CATHETER COULD BE TAKEN OUT OF THE BODY. THE SUTURE REMAINED IN THE BODY WITH THE PROXIMAL END OF IT EXTENDING OUT OF THE BODY FROM THE EXTERNAL FISTULA (PUNCTURED SITE). THE PHYSICIAN LEFT THE SUTURE AS IT WAS AND WILL DISCUSS HOW TO RETRIEVE IT WITH THE PHYSICIAN OF THE TRAUMA DEPARTMENT. THERE WERE NO ADVERSE EFFECTS TO THE PT. NEW INFO RECEIVED ON (B)(4) 2014: THE PROXIMAL END OF THE SUTURE EXTENDING OUT OF THE BODY WAS CUT AND THE PART OF THE SUTURE REMAINED IN THE BODY WAS DETERMINED TO BE EMBEDDED IN THE BODY AS IT IS. THE PT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408062 ULTRATHANE MULTIPURPOSE DRAINAGE SET CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other