BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 10600120 · Received September 29, 2020

    Report

    Report Number
    3006425876-2020-00864
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 14, 2020
    Report Date
    September 14, 2020
    Product Code
    CAZ
    PMA / PMN Number
    K103658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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-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 & POLYMERS (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. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE ROOT CAUSE FOR THIS COMPLAINT INVESTIGATION COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ACTUAL SAMPLE. 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 IS LEAKY.

    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 IS LEAKY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064547 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ IPN046311 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1