BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICC KIT

    MDR report key: 1884216 · Received June 11, 2010

    Report

    Report Number
    1036844-2010-00106
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    February 28, 2009
    Report Date
    April 26, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K930129
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RECEIVED ONE 1-L CATHETER WITH STYLET INSIDE. VISUAL EXAM SHOWED CATHETER WAS CUT AFTER 30 CM MARK, OTHER PIECE WAS RETURNED WITH BLUE TIP INTACT. NO DEFECTS OR ANOMALIES OBSERVED WITH CATHETER. STYLET RETURNED INSERTED IN CATHETER AND PROTRUDING FROM BOTH EXTENSION LINE HUB AND DISTAL (CUT) END OF CATHETER AND WAS STILL PROTRUDING FROM T-PORT CONNECTOR, WHICH WAS DISCONNECTED FROM EXTENSION LINE HUB AND REMAINED CONNECTED TO CATHETER THROUGH STYLET. STYLET WAS UNRAVELED AT EACH EXPOSED POINT. WELD WAS NOT PRESENT ON DISTAL END OF STYLET. STYLET WAS REMOVED FROM THE CATHETER WITH A SLIGHT TUG; HOWEVER, DUE TO CONDITION OF STYLET, OD AND LENGTH COULD NOT BE DETERMINED. FUNCTIONAL TEST WAS PERFORMED WITH LAB INVENTORY STYLET, WHICH WAS INSERTED AND REMOVED THROUGH LUER HUB OF CATHETER WITH NO RESISTANCE. CUSTOMER INDICATED EXPERIENCING A LOT OF RESISTANCE WHILE REMOVING STYLET AND THAT WIRE SEEMED TO BE HUNG UP ON CATHETER WALL. IFU CAUTIONS: PRIOR TO CATHETER PLACEMENT, USER IS NOT TO CUT THE PLACEMENT WIRE WHEN TRIMMING THE CATHETER AND THEN TO CHECK THE TRIMMED CATHETER FOR EVIDENCE OF THE WIRE BEING DAMAGED OR CUT; IF THE DAMAGE IS FOUND NOT TO USE IT. IFU ALSO STATES THAT ONCE CATHETER IS PLACED TO REMOVE THE STYLET/PLACEMENT WIRE AND LUER-LOCK SIDE ARM ASSEMBLY FROM THE CATHETER AS A UNIT. IT IS NOT CLEAR FROM INFO AND SAMPLE PROVIDED IF CUSTOMER IS FOLLOWING IFU, IF THEY CHECKED FOR WIRE DAMAGE PRIOR TO USE, AND IF THEY ARE ATTEMPTING TO REMOVE STYLET AND SIDE ARM AS A UNIT BY UNSCREWING LUER CONNECTOR TO OR INSTEAD ARE PULLING STYLET HUB FROM T-PORT. IN RETURNED SAMPLE, STYLET EXHIBITED UNRAVELED WIRE AT MULTIPLE POINTS AND MISSING WELD, CONFIRMING CUSTOMER'S REMOVAL DIFFICULTY. A DHR REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE REPORTED COMPLAINT WAS CONFIRMED THROUGH VISUAL EXAM AND THE POTENTIAL CAUSE OF THIS ISSUE IS PROCEDURE/PT ANATOMY BASED ON CONDITION OF RETURNED SAMPLE AND REMOVAL DIFFICULTY CUSTOMER DESCRIBED. THIS IS ONE OF 3 RECORDS REFLECTING OCCURRENCES (B)(4). ADDITIONAL OCCURRENCES ARE DOCUMENTED AS MDR #1036844-2009-00055, MDR #1036844-2009-00107. UNTIL JUL 27, 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM JAN 1, 2009 THROUGH JUL 27, 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND (B)(6) REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THIS PROCEDURE WAS BEING PERFORMED ON A (B)(6) MALE IN HIS UPPER ARM CEPHALIC VEIN. THIS IS THE SECOND EVENT INVOLVING THE SAME PT. THE CLINICIAN EXPERIENCED DIFFICULTY AND HAD AN MD INTERVENE. IT WAS DISCOVERED THAT THERE WAS A LOT OF RESISTANCE WHILE TRYING TO REMOVE THE STYLET GUIDEWIRE THAT IS PRE-INSERTED INTO THE CATHETER. ATTEMPTS WERE MADE TO TRY AND REMOVE THE CATHETER WIRE, BUT EACH TIME THE WIRE STARTED TO UNRAVEL INSIDE THE CATHETER, WHICH WAS IN THE PT. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC KIT PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. RF8096965

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR