BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ANESTHESIA KIT

    MDR report key: 8041346 · Received November 6, 2018

    Report

    Report Number
    3006425876-2018-00699
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 19, 2018
    Report Date
    October 19, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSP
    PMA / PMN Number
    K911260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. HOWEVER, THE CUSTOMER DID PROVIDE A PHOTO THAT APPEARS TO SHOW A NEEDLE'S BENT CANNULA. HOWEVER, BASED ON THE RETURNED PHOTO, IT APPEARS TO BE AN INJECTION NEEDLE AND NOT AN INTRODUCER NEEDLE AS DESCRIBED IN THE COMPLAINT DESCRIPTION. A REVIEW OF DESIGN CHANGE HISTORY FOR KIT ASA-25090-SBS AND PART NUMBERS N-25090-002, K-09903-032, AND K-04020-009 WAS PERFORMED AS A PART OF THIS INVESTIGATION. NO DESIGN CHANGES HAVE BEEN MADE TO THIS PRODUCT IN THE PAST TWO YEARS THAT WOULD HAVE LED TO THIS COMPLAINT. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. HOWEVER, THE REPORTED COMPLAINT OF A NEEDLE BENDING DURING USE WAS CONFIRMED BASED ON A PHOTO PROVIDED FROM THE CUSTOMER. VISUAL EXAMINATION OF THE CUSTOMER'S PROVIDED PHOTO APPEARS TO SHOW A BENT CANNULA FOR AN INJECTION NEEDLE AND NOT AN INTRODUCER NEEDLE AS DESCRIBED IN THE COMPLAINT DESCRIPTION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, BASED ON THE PHOTO PROVIDED, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRODUCER NEEDLES ARE VERY FLIMSY, AND THE NEEDLE BENT BADLY WHEN IT HIT BONE. THERE WAS CONCERN THAT IT WOULD BREAK.

    Additional Manufacturer Narrative · 1

    QN# (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRODUCER NEEDLES ARE VERY FLIMSY, AND THE NEEDLE BENT BADLY WHEN IT HIT BONE. THERE WAS CONCERN THAT IT WOULD BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881015 SPINAL ANESTHESIA KIT NEEDLE, CONDUCTION, ANESTHETI BSP ARROW INTERNATIONAL INC. 23F18J0234

    Patients

    Seq Age Sex Outcome Treatment
    1