BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YUEH CENTESIS CATHETER NEEDLE

    MDR report key: 5046167 · Received September 1, 2015

    Report

    Report Number
    1820334-2015-00576
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 25, 2015
    Manufacturer
    COOK INC
    Product Code
    GBO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DTVN-5.0-19-15.0-YUEH-RDC-070896. (B)(4). EVENT EVALUATION: A REVIEW OF COMPLAINT HISTORY, DRAWINGS, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND A VISUAL INSPECTION OF THE RETURNED USED PRODUCT WAS CONDUCTED DURING THE INVESTIGATION. THE RETURNED PACKAGING CONTAINED ONE CATHETER AND ONE HUB (SEPARATED); HOWEVER, THE NEEDLE, OBTURATOR, AND PEEL AWAY STRAIGHTER WERE NOT PRESENT. A VISUAL EXAMINATION REVEALED THE TOTAL LENGTH OF THE CATHETER WAS 15 CM. IT HAD A FRENCH SIZE OF 5, BUT THE PROXIMAL END HAD A FRENCH SIZE OF 6 (DUE TO FLARING). ALL FOUR SIDEPORTS WERE PRESENT AND INTACT AT THE DISTAL END. THE FLARE ON THE HUB WAS FOUND TO BE UNEVEN AND JAGGED AND MEASURED .0845 INCHES IN DIAMETER. THE LOT RECORDS OF THE DEVICE WERE REVIEWED AND NO ISSUES CONCERNING THE QUALITY OF THE PRODUCT RELATIVE TO THIS INVESTIGATION WERE NOTED. QUALITY CONTROL DEPARTMENTS PERFORM A 100% INSPECTION, VERIFYING EACH DEVICE IS FREE FROM BENDS, KINKS, HAS ADEQUATE JOINT STRENGTH, CORRECT OUTSIDE DIMENSION AND OTHER SURFACE IMPERFECTIONS PRIOR TO TRANSPORT. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THE EXPERIENCED DIFFICULTY COULD NOT BE DETERMINED. WE ARE CONTINUING TO MONITOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL OF THIS EVENT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE TIP OF THE CATHETER BROKE OFF INSIDE OF THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP WITH NO HARM TO THE PATIENT. NO ADDITIONAL INTERVENTION OR PROCEDURES WERE REQUIRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE TIP OF THE CATHETER BROKE OFF INSIDE OF THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP WITH NO HARM TO THE PATIENT. NO ADDITIONAL INTERVENTION OR PROCEDURES WERE REQUIRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576954 YUEH CENTESIS CATHETER NEEDLE GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1