BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAL VENOUS CATHETER, HEPARIN COATED

    MDR report key: 5813887 · Received July 21, 2016

    Report

    Report Number
    2025816-2016-00069
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Date of Event
    June 19, 2016
    Report Date
    July 22, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K961552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A TWO (2) YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST/SIMILAR PROBLEM DID NOT RECORD ANY ADDITIONAL REPORTS AND INVESTIGATIONS. RECEIVING ANALYSIS: RECEIVED ON 6/27/2016 - ONE USED 41401-23, CENTRAL VENOUS CATHETER, HEPARIN COATED, 3 LUMEN, 16/18/18 G, 20 CM, PMAP, EXPANDED KIT, LOT# UNKNOWN. TWO FEMALE LUER CAPS. THE CAPS WERE ADDED TO THE PROXIMAL AND MIDDLE LINES. THE HOLE (SLIT) WAS CONFIRMED IN THE CATHETER JUST AFTER THE TRIANGLE UNION. FUNCTIONAL TESTING: THE 41401-23 WAS CHECKED UNDER A MICROSCOPE (10X) AND A HOLE (SLIT) IN THE CATHETER JUST ABOVE THE CATHETER TRIANGLE HUB WAS OBSERVED. THERE WERE NO PINCH MARKS OR VOIDS SEEN AT THE TEAR. THE HOLE (SLIT) WAS IN THE WALL OF THE DISTAL LUMEN. THE 41401-23 DEVICE WAS LEAK TESTED WITH WATER AT GRAVITY PRESSURE AND FOUND A LEAK AT THE CATHETER WHERE THE HOLE (SLIT) IS PRESENT (WALL OF THE DISTAL LUMEN). THE OTHER TWO LUMENS WERE LEAK TESTED WITH WATER AT FOR 10 SECONDS AND FOUND NO LEAKS. DIMENSIONAL ANALYSIS: THE WALL THICKNESS WAS MEASURED ABOVE THE HOLE (SLIT) IN THE CATHETER AND NEAR THE TIP AND FOUND TO BE WITH IN SPECIFICATION. ANALYSIS SUMMARY: THE REPORTED PRODUCT PROBLEM FOR HOLE IN CATHETER WAS CONFIRMED. HOWEVER THE EXACT CAUSE FOR THE HOLE (SLIT) IN THE CATHETER COULD NOT BE DETERMINED. THIS WAS BASED UPON THAT THE WALL THICKNESS OF THE CATHETER DISTAL LUMEN WAS FOUND TO BE WITHIN THE SPECIFICATION REQUIREMENTS AND THERE WERE NO VISIBLE MARKINGS, BLEMISHES OR VOIDS FOUND ON OR IN THE CATHETER EXTERIOR AND LUMEN WHERE THE HOLE WAS LOCATED. THIS INCIDENT DOES APPEAR TO BE AN ISOLATED INCIDENT AT THIS TIME. ICU MEDICAL WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE 41401-23, CENTRAL VENOUS CATHETER, HEPARIN COATED, 3 LUMEN, 16/18/18 G, 20 CM, PMAP, EXPANDED KIT, LOT# UNKNOWN. "POWER INJECTIONS AT 100PSI, POPPED HOLE IN THE CATHETER; 5CC CONTRAS IN INTERSTITIAL TISSUE." THERE WAS MEDICAL/SURGICAL INTERVENTION REPORTED DUE TO AN UNSCHEDULED CHANGE OF DEVICES AND COMPLETE THE OPERATION. THERE WERE NO SERIOUS ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467498 CENTRAL VENOUS CATHETER, HEPARIN COATED CVC FOZ ICU MEDICAL, INC. 41401-23 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1