BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTROCAN SAFETY

    MDR report key: 794671 · Received December 12, 2006

    Report

    Report Number
    2523676-2006-00107
    Event Type
    Other
    Date Received
    December 12, 2006
    Date of Event
    November 9, 2006
    Report Date
    December 5, 2006
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL SAMPLE CONSISTING OF THE CATHETER HUB ATTACHED TO AN UNK EXTENSION SET WAS RETURNED FOR EVALUATION. THE DETACHED CATHETER AND THE CANNULA WERE NOT RETURNED WITH THE SAMPLE. THE INTERNAL STAINLESS STEEL FUNNEL USED TO LOCK THE CATHETER INTO THE HUB COULD CLEARLY BE SEEN AND WAS INTACT. NO PORTION OF THE CATHETER REMAINED INSIDE THE HUB. ALTHOUGH A LOT NUMBER WAS NOT PROVIDED, TWENTY-FIVE UNUSED SAMPLES FROM CURRENT INVENTORY WERE SUBJECTED TO A PULL TEST OF THE CATHETER TO HUB JOINT UNTIL FAILURE USING A TENSILE FORCE TESTER. ALL SAMPLES EXCEEDED THE MINIMUM JOINT SEPARATION DESIGN SPECIFICATION AND PASSED THE PULL TEST. THE SAMPLE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED TO THE ACTUAL MANUFACTURER, B. BRAUN MEDICAL INDUSTRIES SDN BHD, IN MALAYSIA.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE FACILITY: A PT WAS TRANSFERRED FROM ICU TO MED SURG. THE NURSE NOTED THAT THE IV CATHETER WAS MISSING FROM THE HUB. UNABLE TO LOCATE THE CATHETER BUT OBTAINED AN X-RAY OF THE EXTREMITY WHICH REVEALED NO EVIDENCE OF THE CATHETER. THE HUB WAS RECOVERED FOR SAMPLE. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE PATIENT SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT AND THE CATHETER WAS NOT LOCATED UNDER X-RAY. THE LOT NUMBER REMAINS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other