BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 9304380 · Received November 11, 2019

    Report

    Report Number
    3006425876-2019-00865
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 16, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K103658
    Adverse Event
    Yes
    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 (REFERENCE ATTACHED FILES INP1900072820). THE SYRINGE WAS VISUALLY EXAMINED. VISUAL EXAMINATION OF THE SYRINGE REVEALED THAT THE SYRINGE APPEARS TYPICAL BUT USED AS BIOLOGICAL MATERIAL CAN BE SEEN ON THE BARREL. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE RETURNED SAMPLE WAS RETURNED TO THE SUPPLIER (PREOX) FOR FUNCTION TESTING. ACCORDING TO THE SUPPLIER, "NO LEAKAGE FOUND BY NORMAL HANDLING, LEAKAGE IF PLUNGER MOVED TO THE SIDE". A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # KZ-05501-002 AS A PART OF THIS COMPLAINT INVESTIGATION. PER (B)(4)(RELEASED 03-DEC-2018), SUPPLIER ((B)(4)) 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 REPORTED COMPLAINT OF THE LOR SYRINGE LEAKING WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. THE RETURNED LOR SYRINGE WAS RETURNED TO THE SUPPLIER (PREOX) FOR FUNCTIONAL TESTING WHERE ACCORDING TO THE SUPPLIER, "NO LEAKAGE FOUND BY NORMAL HANDLING, LEAKAGE IF PLUNGER MOVED TO THE SIDE". A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR SYRINGE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED ISSUE. HOWEVER, BASED ON THE FUNCTIONAL TESTING BY THE SUPPLIER, THE POTENTIAL ROOT CAUSE OF THIS ISSUE IS SUPPLIER RELATED. A SCAR, 50001602, HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BETWEEN (B)(6) 2019 AND (B)(6) 2019, FEW ISSUES HAPPENED. WHILE FILLING THE SYRINGE, THE ANESTHETISTS OBSERVED THAT THE PLUNGER GOES UP BY ITSELF. IT CAUSED LIQUID LEAKS AND AIR LEAKS. THIS OCCURRED BETWEEN THE TIME OF INSERTION AND WHILE IN USE WITH SOME RESISTANCE REGAINED AFTER A WHILE. DOCTORS HAVE ALSO HAD ISSUES WHEN THEY ARE LOOKING FOR THE EPIDURAL SPACE (LOSS OF RESISTANCE). 5 PATIENTS SUFFERED FROM BREACH DURA-MATER, 3 HAD A BLOOD PATCH.

    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 BETWEEN (B)(6) 2019 AND (B)(6) 2019, FEW ISSUES HAPPENED. WHILE FILLING THE SYRINGE, THE ANESTHETISTS OBSERVED THAT THE PLUNGER GOES UP BY ITSELF. IT CAUSED LIQUID LEAKS AND AIR LEAKS. THIS OCCURRED BETWEEN THE TIME OF INSERTION AND WHILE IN USE WITH SOME RESISTANCE REGAINED AFTER A WHILE. DOCTORS HAVE ALSO HAD ISSUES WHEN THEY ARE LOOKING FOR THE EPIDURAL SPACE (LOSS OF RESISTANCE). 5 PATIENTS SUFFERED FROM BREACH DURA-MATER, 3 HAD A BLOOD PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099490 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. 71F19G2970

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention