BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 10599529 · Received September 29, 2020

    Report

    Report Number
    3006425876-2020-00827
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 8, 2020
    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 SEALED REPRESENTATIVE KIT FROM THE SAME LOT # AS REPORTED ON THE COMPLAINT ((B)(4)) FOR INVESTIGATION. THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED. THE RETURNED KIT WAS OPENED AND THE 10ML PLASTIC LOR SYRINGE WAS REMOVED AND WAS VISUALLY EXAMINED. VISUAL EXAMINATION OF THE SYRINGE REVEALED THAT THE SYRINGE APPEARS TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. THE RECEIVED SAMPLE WAS RETURNED TO THE SUPPLIER (PREOX) FOR FUNCTION TESTING. ACCORDING TO THE SUPPLIER, NO LEAK WAS FOUND WITH THE RETURNED SYRINGE. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # KZ-05501-002 AS A PART OF THIS COMPLAINT INVESTIGATION. PER ECO-057562 (RELEASED (B)(6) 2020), SUPPLIER (PREOX) MADE THE FOLLOWING CHANGES: OPTIONAL COMPONENT MATERIALS/MOLD LOCATIONS: OPTION 1: BARREL: POLYPROPYLENE - PROFAX PF-535 LYONDELL-BASELL; PLUNGER: POLYPROPYLENE 100-GA12 INEOS OLEFINS & POLYMRS (MOLDED AT FLEIMA PLASTIC); BLUE STOPPER: SILICONE RUBBER (MOLDED AT ET ELASTOMER TECHNIK). OPTION 2: BARREL: POLYPROPYLENE - PROFAX PF-535 LYONDELL-BASELL; PLUNGER: POLYPROPYLENE PROFAX PF-531 LYONDELL-BASELL (MOLDED AT GPE); BLUE STOPPER: SILICONE RUBBER (MOLDED AT PSILKON). LUBRICANT: THE I.D. OF THE BARREL LUBRICATED W/ MEDICAL GRADE SILICONE (POLYDIMETHYLSILOXAN) AND AMOUNT WILL NOT EXCEED 0.25MG PER SQ CENTIMETER. THESE EFFECTIVE CHANGES DID IMPACT PRODUCT DESIGN AND MATERIAL. IT SHOULD BE NOTED, THE RETURNED LOR SYRINGE WAS FROM THE NEW DESIGN. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE COMPLAINT COULD NOT BE CONFIRMED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ACTUAL COMPLAINT SAMPLE. THE REPRESENTATIVE SAMPLE RECEIVED WAS VISUALLY INSPECTED WITH NO ISSUES. THE SYRINGE WAS RETURNED TO THE SUPPLIER (PREOX) WHERE THE SYRINGE WAS FUNCTIONALLY TESTED WITH NO ISSUE FOUND. THE REPORTED COMPLAINT OF THE LOR SYRINGE LEAKING COULD NOT BE CONFIRMED BASED ON THE SAMPLE RECEIVED. THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED; ONLY A REPRESENTATIVE SAMPLE WAS 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. THEREFORE, A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED OR WITHOUT THE ACTUAL COMPLAINT SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WITH SYRINGES INCLUDED IN KITS JC-05400-B (AFTER THE RECALL), WE FACED 3 INCIDENTS OF THE PLUNGER OF THE LOR SYRINGE LEAKING. THE ANAESTHESISTS WERE NOT ABLE TO LOCATE THE EPIDURAL SPACE AND MADE DURAL TEARS FOR EACH OF THE 3 FEMALE PATIENTS INVOLVED. FOR THE INCIDENT OF THE (B)(6), A BLOOD PATCH WAS APPLIED. NOT FOR THE OTHER TWO. PATIENTS ARE FINE.

    Additional Manufacturer Narrative · 1

    QN# (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITH SYRINGES INCLUDED IN KITS JC-05400-B (AFTER THE RECALL), WE FACED 3 INCIDENTS OF THE PLUNGER OF THE LOR SYRINGE LEAKING. THE ANAESTHESISTS WERE NOT ABLE TO LOCATE THE EPIDURAL SPACE AND MADE DURAL TEARS FOR EACH OF THE 3 FEMALE PATIENTS INVOLVED. FOR THE INCIDENT OF THE 31ST OF AUGUST, A BLOOD PATCH WAS APPLIED. NOT FOR THE OTHER TWO. PATIENTS ARE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063036 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ IPN046311 71F20E0691

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R