BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH

    MDR report key: 776304 · Received August 28, 2006

    Report

    Report Number
    2925153-2006-00026
    Event Type
    Other
    Date Received
    August 28, 2006
    Date of Event
    July 10, 2006
    Report Date
    August 28, 2006
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY HUB WITH LOOSE CLEAR FEMALE LUER FITTING WAS RETURNED FOR EVALUATION. SAMPLE WILL BE SENT OUT TO THE STERILIZER ON THE NEXT AVAILABLE LOAD FOR DECONTAMINATION PRIOR TO PHYSICAL EVALUATION. THIS TYPE OF INCIDENT WAS REPORTED ONLY BY THIS INSTITUTION, WHICH USES THE MPS ACACIA EXTENSION SET WITH THE V-CATH. SIMILAR INCIDENTS (FROM HOSPITAL) WERE REPORTED UNDER MDRS #: 2925153-2006-16 AND 2925153-2006-17. BOTH INVESTIGATIONS CONCLUDED THE FOLLWING: THE FEMALE LUER FITTING IN THE CATHETERT HUB WAS DAMAGED AND PULLED OUT WHEN ATTEMPTING TO DISCONNECT THE MFS EXTENSION SET. THE MPS EXTENSION SET IS POORLY DESIGNED WITH A FIXED LUER NUT THAT REQUIRES THE MALE LUER TAPER TO ROTATE WHEN ATTEMPTING TO UNSCREW THE LUER CONNECTION, CAUSING THE MALE LUER OF THE EXTENSION SET TO STICK TIGHTLY IN THE FEMALE LUER OF THE CATHETER. THE FEMALE LUER FITTING OF THE CATHETER HAS BEEN IN USE FOR MORE THAN TEN YEARS WITH OVER HALF A MILLION LUER FITTINGS IN SERVICE WITHOUT CONNECTION DIFFICULTIES. HOSPITAL HAS BEEN USING THE 2FR V-CATH SINCE 1999 WITHOUT PRBLEMS UNTIL NOW. WHERE THE NEW EXTENSION SET, MFS ACACIA, IS INTRODUCED TO BE USED WITH THE V-CATH.

    Description of Event or Problem · 1

    " HUB CAME APART WITH LINE CHARGE. OLD IV TUBING REMOVED, NEW IV TUBING CONNECTED TO HUB. A FEW SECOND LATER, NURSE LOOKED AT PATIENT TO FIND APART INNER PIECE OF HUB ATTACHED TO NEW TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH ACCESS DEVICE DQO HDC CORP. 2015-1640 1009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN