BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER

    MDR report key: 2950338 · Received February 6, 2013

    Report

    Report Number
    2026095-2013-00026
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE HAS NOT YET BEEN REC'D, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: AT THIS TIME, THE LOT INFO AND CATHETER MODEL ARE UNK. AN EVAL AND INVESTIGATION IS PENDING RECEIPT OF THE SAMPLE. CONCLUSIONS: A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. RECOMMENDATIONS FOR REMOVING: ACCORDING TO THE ON-Q DIRECTIONS FOR USE: "IF RESISTANCE IS ENCOUNTERED DURING REMOVAL, OR IF THE CATHETER STRETCHES, STOP. IT IS ADVISABLE TO WAIT 30-60 MINS AND TRY AGAIN. THE PT'S BODY MOVEMENTS MAY RELIEVE THE CATHETER TO ALLOW EASIER REMOVAL. IF THE CATHETER IS STILL DIFFICULT TO REMOVE, AN X-RAY IS RECOMMENDED." INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: BUPIVACAINE 0.25%, FILL VOLUME: UNK, FLOW RATE: 4ML/HR, PROCEDURE: RIGHT ILIAC CREST BONE HARVEST, CATHPLACE: RIGHT THIGH TO ILIAC CREST. RIGHT ILIAC CREST BONE GRAFT HARVEST SITE, DOS: (B)(6) 2012. SURGEON REPORTED THAT WHILE HE WAS REMOVING THE CATHETER HE MET SOME RESISTANCE. "THERE WAS TENSION ON CLOSURE, CHILD MOVED, I PULLED OUT THE CATHETER". THE SURGEON STATED THAT IT APPEARS TO BE ONLY THE TIP THAT WAS LEFT INSIDE THE PT; ESTIMATES THE CATHETER SEGMENT TO BE ABOUT 3MM IN LENGTH. HE REPORTED THAT THE CATHETER APPEARED STRETCHED AT THE BREAK POINT AND COMMENTED THAT BONE MAY HAVE INTERFERED WITH THE CATHETER. THE PT HAD AN X-RAY TO DETERMINE WHETHER TO LEAVE THE BROKEN PIECE IN OR NOT. THE CATHETER FRAGMENT WAS NOT REMOVED. PT STATUS: REPORTED NO PROBLEM. THE CATHETER WAS USED WITH PUMP MODEL: ON-Q: P400X4D 400ML, X DUAL 2ML/HR, PUMP CATALOG #: 101367600 LOT #: 0200623811.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50590 CATHETER CATHETER BSO I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other