BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 9757703 · Received February 26, 2020

    Report

    Report Number
    3006425876-2020-00190
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 12, 2020
    Report Date
    February 12, 2020
    Product Code
    CAZ
    PMA / PMN Number
    K103658
    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. 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. 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. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS PROVIDED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOR SYRINGE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOR SYRINGE WAS LEAKING THE SYRINGE HAD NO RESISTANCE. IT HAPPENED FOR 3 SYRINGES IN A ROW. THE STAFF IN THE THEATER ROOM OPENED 3 KITS WITH SYRINGES HAVING THE SAME ISSUE. THE LOT WAS PUT IN QUARANTINE. ADDITIONAL INFORMATION INDICATES THAT THERE WAS NO PATIENT INJURY AND THE LEAK WAS AIR FOUND UPON OPENING THE KIT.

    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 LOR SYRINGE WAS LEAKING THE SYRINGE HAD NO RESISTANCE. IT HAPPENED FOR 3 SYRINGES IN A ROW. THE STAFF IN THE THEATER ROOM OPENED 3 KITS WITH SYRINGES HAVING THE SAME ISSUE. THE LOT WAS PUT IN QUARANTINE. ADDITIONAL INFORMATION INDICATES THAT THERE WAS NO PATIENT INJURY AND THE LEAK WAS AIR FOUND UPON OPENING THE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216390 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ IPN046311 71F19J2204

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.