BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTIP PLUS CLOSED-TIP MULTIPORT EPIDURAL CAT

    MDR report key: 6910264 · Received October 3, 2017

    Report

    Report Number
    1036844-2017-00370
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 26, 2017
    Report Date
    September 26, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO KIT OR LOT NUMBER WERE PROVIDED BY THE CUSTOMER. THEREFORE, A REVIEW OF SALES HISTORY DATA COULD NOT BE PERFORMED TO OBTAIN A LOT NUMBER. VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION. HOWEVER, THE CUSTOMER DID PROVIDE A PHOTO THAT CLEARLY SHOWS A EPIDURAL NEEDLE THAT LOOKS TO HAVE A BENT TIP (REFERENCE FILES (B)(4)). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. HOWEVER, THE REPORTED COMPLAINT OF A BENT NEEDLE WAS CONFIRMED BASED ON A PHOTO PROVIDED FROM THE CUSTOMER. VISUAL EXAMINATION OF THE CUSTOMER PROVIDED PHOTO REVEALED A EPIDURAL NEEDLE THAT WAS BENT AT THE TIP. THE DEVICE HISTORY RECORDS WERE NOT REVIEWED AS NO KIT OR LOT NUMBER WERE PROVIDED BY THE CUSTOMER AND THEREFORE, NO SALES HISTORY RECORDS COULD BE FOUND FROM THIS CUSTOMER FOR THIS PRODUCT. THEREFORE, BASED ON THE PHOTO PROVIDED, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE IS NOT EXPECTED TO BE RETURNED SINCE THE COMPLAINT WAS BASED ON AN ARTICLE. AN INVESTIGATIVE REVIEW HAS NOT BEEN SUBMITTED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    PER ARTICLE RECEIVED FROM A PUBLICATION: A (B)(6) NON-OBESE MAN WITH NO HISTORY OF SPINE DISEASE PRESENTED FOR EXPLORATORY LAPAROTOMY. A 19-GA CATHETER (FLEXTIP PLUS, MULTIPORT, ARROW INC.) WAS ADVANCED THROUGH THE NEEDLE, BUT IT WAS IMPOSSIBLE TO THREAD IT PAST 11.5 CM, CORRESPONDING TO THE TIP OF THE NEEDLE. CLOSE EXAMINATION OF THE EPIDURAL NEEDLE REVEALED A SMALL KINK AT THE TIP, MAKING PASSAGE OF THE CATHETER IMPOSSIBLE. WHEN A NEW NEEDLE WAS USED WITH THE SAME APPROACH, THE CATHETER WAS PASSED EASILY AND GOOD ANALGESIA WAS OBTAINED.

    Description of Event or Problem · 1

    PER ARTICLE RECEIVED FROM A PUBLICATION: A (B)(6) NON-OBESE MAN WITH NO HISTORY OF SPINE DISEASE PRESENTED FOR EXPLORATORY LAPAROTOMY. A 19-GA CATHETER (FLEXTIP PLUS, MULTIPORT, ARROW INC.) WAS ADVANCED THROUGH THE NEEDLE, BUT IT WAS IMPOSSIBLE TO THREAD IT PAST 11.5 CM, CORRESPONDING TO THE TIP OF THE NEEDLE. CLOSE EXAMINATION OF THE EPIDURAL NEEDLE REVEALED A SMALL KINK AT THE TIP, MAKING PASSAGE OF THE CATHETER IMPOSSIBLE. WHEN A NEW NEEDLE WAS USED WITH THE SAME APPROACH, THE CATHETER WAS PASSED EASILY AND GOOD ANALGESIA WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690709 FLEXTIP PLUS CLOSED-TIP MULTIPORT EPIDURAL CAT ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1