BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 10033251 · Received May 7, 2020

    Report

    Report Number
    3006425876-2020-00408
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    April 21, 2020
    Report Date
    April 21, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR SYRINGE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE LOR SYRINGE LEAKED. THE CUSTOMER RETURNED ONE 10ML PLASTIC LOR SYRINGE. THE SYRINGE WAS VISUALLY EXAMINED. VISUAL EXAMINATION OF THE SYRINGE REVEALED THAT THE SYRINGE APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. THE RETURNED SAMPLE WAS RETURNED TO THE SUPPLIER (PREOX) FOR FUNCTION TESTING. ACCORDING TO THE SUPPLIER, NO LEAK WAS FOUND WITH THE RETURNED SAMPLE. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # KZ-05501-002 AS A PART OF THIS COMPLAINT INVESTIGATION. PER ECO-051699 (RELEASED 03-DEC-2018), SUPPLIER (PREOX) MADE THE FOLLOWING CHANGES: KZ-05501-002 LUER PLASTIC LOR SYRINGE: A. CHANGED PLUNGER MATERIAL FROM PROFAX 535 TO PROFAX 531 B. CHANGED TO NEW PLUNGER TOOL C. CHANGED TO NEW MOLD FOR BLUE STOPPER D. CHANGED MOLDING LOCATION FOR THE PLUNGER AND THE BLUE STOPPER AS FOLLOWS. - PLUNGER: FROM FLEIMAPLASTIC IN GERMANY TO GPE, GERMANY - BLUE STOPPER: FROM ET, GERMANY TO PSILKON, GERMANY THESE EFFECTIVE CHANGES DID IMPACT PRODUCT DESIGN AND MATERIAL. IT SHOULD BE NOTED, THE RETURNED LOR SYRINGE WAS FROM THE NEW DESIGN. THE RETURNED SAMPLE WAS RETURNED TO THE SUPPLIER (PREOX) FOR FUNCTIONAL TESTING. NO ISSUES WERE FOUND WITH THE RETURNED SAMPLE. THE REPORTED COMPLAINT OF THE LOR SYRINGE LEAKING COULD NOT BE CONFIRMED BASED ON THE SAMPLE RECEIVED. THE RETURNED LOR SYRINGE WAS RETURNED TO THE SUPPLIER (PREOX) FOR FUNCTIONAL TESTING WHERE NO ISSUES WERE FOUND. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR SYRINGE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED ISSUE. BASED ON THE SUPPLIER'S RESULTS, NO ISSUES WERE FOUND WITH THE RETURNED SAMPLE. OTHER REMARKS:

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LEAKAGE OF THE LOR SYRINGE.

    Additional Manufacturer Narrative · 1

    (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 THERE WAS LEAKAGE OF THE LOR SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495840 EPIDURAL CATHETERIZATION KIT EPIDURAL ANESTHESIA KIT OGE ARROW INTERNATIONAL INC. IPN046029 71F20B2179

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.