BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH

    MDR report key: 775677 · Received August 29, 2006

    Report

    Report Number
    2925153-2006-00027
    Event Type
    Other
    Date Received
    August 29, 2006
    Report Date
    August 28, 2006
    Manufacturer
    HDC CORP.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL BE SENT TO THE STERILIZER ON THE NEXT AVAILABLE LOAD FOR DECONTAMINATION PRIOR TO PHYSICAL EVALUATION. THIS TYPE OF INCIDENT WAS REPORTED ONLY BY THIS INSTITUTION, HOSP, WHICH USES THE MPS ACACIA TID-360B EXTENSION SET (NOT MANUFACTURED BY HDC) WITH THE V-CATH. SIMILAR INCIDENTS (FROM THIS HOSPITAL) WERE REPORTED UNDER MDR'S #:2925153-2006-16, AND 2925153-2006-17. BOTH INVESTIGATIONS CONCLUDED THE FOLLOWING: THE FEMALE LUER FITTING IN THE CATHETER HUB WAS DAMAGED AND PULLED OUT WHEN ATTEMPTING TO DISCONNECT THE MPS 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 HAD BEEN USING THE 2FR V-CATH SINCE 1999 WITHOUT PROBLEMS UNTIL NOW, WHERE THE NEW EXTENSION SET, MPS ACACIA, IS INTRODUCED TO BE USED WITH THE V-CATH. ANOTHER SIMILAR INCIDENT WAS REPORTED UNDER MDR # 2925153-2006-26. FILING THIS AS MDR BECAUSE COMPLAINANT WAS UNABLE TO PROVIDE MORE INFORMATION ON THE INCIDENT.

    Description of Event or Problem · 1

    "BROKE" -- NO MORE INFORMATION WAS PROVIDED !!!

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN