BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 7148519 · Received December 27, 2017

    Report

    Report Number
    3006425876-2017-00588
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    December 10, 2017
    Report Date
    December 13, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN# (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE KIT AND THE LOR SYRINGE WITH NO FINDINGS RELEVANT TO THIS COMPLAINT. THE CUSTOMER REPORTED THAT THE LOR SYRINGE BROKE DURING MEDICAL INJECTION. THE CUSTOMER ALSO INDICATED THE SYRINGE WAS DROPPED AND DAMAGED AFTER USE. THE CUSTOMER RETURNED ONE GLASS LOR SYRINGE. THE RETURNED SYRINGE WAS VISUALLY EXAMINED. VISUAL EXAMINATION REVEALED THAT THE TIP IS BROKEN FROM THE BARREL. ALSO, THE BARREL IS BROKEN INTO SEVERAL PIECES. THE PACKAGING CONFIGURATION FOR THE KIT WAS REVIEWED AND THE SYRINGE IS LOCATED IN A TRAY CAVITY THAT IS SEPARATED FROM OTHER COMPONENTS. NO CORRECTIVE ACTION IS NEEDED AT THIS AS THE ROOT CAUSE FOR THIS COMPLAINT INVESTIGATION WAS UNDETERMINED. THE REPORTED COMPLAINT OF A BROKEN LOR SYRINGE WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED OTHER REMARKS: BASED ON THE DAMAGED OBSERVED TO SYRINGE AND THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER FOUND SLIGHT CRACK-LOOK DAMAGE ON THE LOR, BUT CONTINUED TO USE IT. AT INJECTION OF THE MEDICAL AGENT, THE LOR GOT BROKEN. THERE WAS NO REPORTED PATIENT INJURY. AFTER THIS EVENT OCCURRED, THE LOR WAS DROPPED ON THE FLOOR; THE RETURNED SAMPLE WOULD BE SERIOUSLY DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER FOUND SLIGHT CRACK-LOOK DAMAGE ON THE LOR, BUT CONTINUED TO USE IT. AT INJECTION OF THE MEDICAL AGENT, THE LOR GOT BROKEN. THERE WAS NO REPORTED PATIENT INJURY. AFTER THIS EVENT OCCURRED, THE LOR WAS DROPPED ON THE FLOOR; THE RETURNED SAMPLE WOULD BE SERIOUSLY DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927534 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. 71F17E2167

    Patients

    Seq Age Sex Outcome Treatment
    1