BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    MDR report key: 1884248 · Received June 11, 2010

    Report

    Report Number
    1036844-2010-00039
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    January 13, 2009
    Report Date
    March 3, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RECEIVED ONE 3-LUMEN CVC AND GUIDE WIRE. THE GUIDE WIRE IS UNRAVELED AT THE PROXIMAL END AND SHARPLY KINKED NEAR DISTAL TIP. THE GUIDE WIRE WAS EXAMINED MICROSCOPICALLY. THE CORE WIRE IS SEPARATED ADJACENT TO THE PROXIMAL WELD. THE PROXIMAL WELD REMAINS ATTACHED TO THE COIL WIRE. THE DISTAL WELD IS INTACT. THE COMPLAINT REPORT STATES THAT ON TWO OCCASIONS, THE GUIDE WIRE UNRAVELED WHILE BEING REMOVED FROM THE FEED TUBE. NEITHER GUIDE WIRE WAS USED. THE PACKAGING CONFIGURATION OF THIS GUIDE WIRE INCLUDES A PROTECTIVE FEED TUBE ASSEMBLY. THE PROXIMAL END OF THE GUIDE WIRE PROTRUDES FROM A CAP WHICH HOLDS THE WIRE IN PLACE WITHIN THE FEED TUBE. THE FEED TUBE ASSEMBLY WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS FOR THE GUIDE WIRE WERE REVIEWED WITH NO FINDINGS RELEVANT TO THIS COMPLAINT. THE REPORTED COMPLAINT OF GUIDE WIRE UNRAVELING WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETUNED SAMPLE. THE POTENTIAL CAUSE OF UNRAVELING COULD NOT DETERMINED BASED UPON THE INFO PROVIDED AND WITHOUT THE FEED TUBE ASSEMBLY. THIS IS ONE OF 2 RECORDS REFLECTING MULTIPLE OCCURRENCES OF MFR CONTROL (B)(4). ADD'L OCCURRENCES ARE DOCUMENTED AS MDR # 1036844-2009-00022. UNTIL JULY 27, 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM (B)(6) 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND (B)(6) REPORTS. PLEASE REFER TO THE MDR FOR THE ORIGINAL COMPLAINT REFERENCED ABOVE FOR THE FOLLOW-UP FOR THIS MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THEY HAD AN INCIDENT DURING INSERTION AND THE SPRING WIRE GUIDE (SWG) SEEMED TO "SHRED". ADD'L INFO RECEIVED ON (B)(6) 2009 FROM THE INTENSIVE CARE UNIT MANAGER STATED THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE SWG FROM THE FEED TUBE. AT WHICH TIME, HE "PULLED" THE SWG FROM THE TUBE AND NOTICED IT WAS SHREDDED. AS A RESULT, IT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF8045297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK