BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS STOPCOCK AND MANI FOLD COMPONENT

    MDR report key: 1884214 · Received June 11, 2010

    Report

    Report Number
    3005789918-2010-00011
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    January 12, 2009
    Report Date
    March 25, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FPA
    PMA / PMN Number
    K830755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL. THIS IS ONE OF 5 RECORDS REFLECTING OCCURRENCES OF MFR CONTROL# 8668. ADDITIONAL OCCURRENCES ARE DOCUMENTED AS MDR #3005789918-2009-00002, MDR #3005789918-2010-00012, MDR #3005789918-2010-00013, MDR #3005789918-2010-00014. UNTIL (B)(4) 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM (B)(4) 2009 THROUGH (B)(4) 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND CANADIAN REPORTS. PLEASE REFER TO THE MDR FOR THE ORIGINAL COMPLAINT REFERENCED ABOVE FOR THE F/U FOR THIS MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THEY WERE USING THE W20979 AS A SUBSTITUTE PRODUCT FOR W21372 WHICH IS CURRENTLY UNAVAILABLE. AS LONG AS THEY'VE BEEN USING THE W20979, THEY HAVE EXPERIENCED DIFFICULTY WITH THE STOPCOCK LEAKING. THESE ARE USED IN VARIOUS PARTS OF THE HOSP. IN THE NEONATAL INTENSIVE CARE UNIT (NICU), THEY ARE INFUSING LIPIDS, IN NUCLEAR MEDICINE AND SURGICAL INTENSIVE CARE UNIT (SICU), THEY ARE INFUSING IV MEDS AND THESE ARE JUST A FEW PLACES THEY ARE BEING USED AT THE FACILITY. THERE HAVE BEEN NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALRUS STOPCOCK AND MANI FOLD COMPONENT WALRUS PRODUCTS FPA ARROW INTERNATIONAL INC ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK