BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 11615913 · Received April 5, 2021

    Report

    Report Number
    3006425876-2021-00302
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    March 24, 2021
    Report Date
    March 24, 2021
    Product Code
    CAZ
    UDI-DI
    40801902029674
    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 TWO 10ML PLASTIC LOR SYRINGES AND LIDSTOCK. THE SYRINGES WERE VISUALLY EXAMINED. VISUAL EXAMINATION OF THE SYRINGES REVEALED THAT THE SYRINGES APPEAR 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 EITHER RETURNED SYRINGE. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # KZ-05501-002 AS A PART OF THIS COMPLAINT INVESTIGATION. PER ECO-057562 (RELEASED 12-MAR-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. IT SHOULD BE NOTED, THE RETURNED LOR SYRINGES WERE FROM THE NEW DESIGN. THE RETURNED SAMPLE WAS RETURNED TO THE SUPPLIER (PREOX) FOR FUNCTIONAL TESTING. NO ISSUES WERE FOUND WITH EITHER RETURNED SAMPLE. THE REPORTED COMPLAINT OF THE LOR SYRINGE LEAKING COULD NOT BE CONFIRMED BASED ON THE SAMPLE RECEIVED. THE RETURNED LOR SYRINGES WERE 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.

    Description of Event or Problem · 0

    A ANAESTHESIST IS REPORTING THAT HE BELIEVES THERE WAS A CHANGE ON THE PLUNGER OF THE LOR SYRINGE. HE IS WONDERING IF SPECIFICATIONS CHANGED BECAUSE HE STATED THAT THERE IS A LOSS OF SENSATION OF THE PLUNGER. PUNCTURE OF THE DURA OCCURRED WHILE SEARCHING TO THE EPIDURAL SPACE. APPLICATION OF A BLOOD PATCH WAS PERFORMED AS INTERVENTION.

    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

    AN ANAESTHESIST IS REPORTING THAT HE BELIEVES THERE WAS A CHANGE ON THE PLUNGER OF THE LOR SYRINGE. HE IS WONDERING IF SPECIFICATIONS CHANGED BECAUSE HE STATED THAT THERE IS A LOSS OF SENSATION OF THE PLUNGER. PUNCTURE OF THE DURA OCCURRED WHILE SEARCHING TO THE EPIDURAL SPACE. APPLICATION OF A BLOOD PATCH WAS PERFORMED AS INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513476 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ IPN046311 40801902029674

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention