BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION SET

    MDR report key: 10536546 · Received September 15, 2020

    Report

    Report Number
    3006425876-2020-00789
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    August 17, 2020
    Report Date
    August 26, 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. 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 ((B)(4)) 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 ("POLYDIMETHYLSILOXANE") 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 PLUNGER IS AIR LEAKING. THE DOCTOR(ANESTHETIST)FACED 2 INCIDENTS DURING THE NIGHT OF WEDNESDAY (B)(6) OF (B)(6) 2020. WITH 2 DIFFERENT LOT NUMBERS. LOT#:71F20E0804 AND 71F20E0956. THERE WAS NO CONSEQUENCE FOR THE TWO FEMALE PATIENTS BUT A RISK. DURING THE WEEK 35 ((B)(6) 2020),ANOTHER DOCTOR(ANESTHETIST) FACED 2 INCIDENTS WITH LOT# 71F20E0804 AND 71F20E095. THE CONSEQUENCES FOR THE 2 FEMALE PATIENTS WERE: DURA MATER BREACHES SO A BLOOD PATCH HAD TO BE APPLIED FOR EACH.

    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 THE PLUNGER IS AIR LEAKING. THE DOCTOR(ANESTHETIST)FACED 2 INCIDENTS DURING THE NIGHT OF WEDNESDAY (B)(6) 2020. WITH 2 DIFFERENT LOT NUMBERS. LOT#:71F20E0804 AND 71F20E0956. THERE WAS NO CONSEQUENCE FOR THE TWO FEMALE PATIENTS BUT A RISK. DURING THE WEEK 35 ((B)(6) 2020), ANOTHER DOCTOR(ANESTHETIST) FACED 2 INCIDENTS WITH LOT# 71F20E0804 AND 71F20E095. THE CONSEQUENCES FOR THE 2 FEMALE PATIENTS WERE: DURA MATER BREACHES SO A BLOOD PATCH HAD TO BE APPLIED FOR EACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001886 EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT CAZ IPN046311 71F20E0804

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention