BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUOHY NEEDLE

    MDR report key: 10374695 · Received August 6, 2020

    Report

    Report Number
    9611612-2020-00009
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 31, 2020
    Report Date
    December 8, 2020
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    14048223004019
    PMA / PMN Number
    K040965
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO FAILURE PRODUCT BUT PICTURES OF THE FAILURE PRODUCT WERE SENT IN FOR EXAMINATION. THE MANUFACTURING DOCUMENTATION AND THE MANUFACTURING SPECIFICATIONS OF THE BATCH CONCERNED WERE EXAMINED AND DID NOT ALLOW ANY NEGATIVE CONCLUSIONS TO BE DRAWN. THE FACTS OF THE CASE WERE EXAMINED. RESULT: THE DEFECT COULD BE TRACED. THE LUER CONNECTION OF THE CANNULA HUB HAS SEPARATED FROM THE REST OF THE HUB. THIS COULD BE CONFIRMED BY EXAMINATION OF THE PICTURES SENT IN BY THE CUSTOMER. WHEN EXAMINING A RETENTION SAMPLE OF THE ARTICLE FROM THE CORRESPONDING BATCH, NO DEVIATIONS COULD BE FOUND. THE LUER CONNECTION COULD NOT BE SEPARATED FROM THE LOR SYRINGE EVEN BY STRONG FORCE AFTER CONNECTING THE SYRINGE. THE CAUSE OF THE ERROR CANNOT BE DETERMINED BEYOND DOUBT WITHOUT EXAMINING THE PRODUCT. WE ARE NOT AWARE OF ANY OTHER COMPLAINTS WITH THIS DEFECT PATTERN AT PRESENT. IT IS POSSIBLY A SINGLE PRODUCT ERROR. BASED ON CLINICAL EVALUATION REPORT AND RISK MANAGEMENT FILE THIS FILE IS CONSIDERED AS CLOSED UNLESS FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IRN#: (B)(4). BROKEN HUB.

    Additional Manufacturer Narrative · 1

    EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH (B)(6) DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL PRODUKTE GMBH. CURRENTLY THE DATA IS POOR AND THE DEVICE HAS NOT BEEN RETURNED/ ANALYSED. AS SOON AS FURTHER DATA WILL BE AVAILABLE A FOLLOW UP REPORT WILL BE SENT IN TO THE AGENCY.

    Description of Event or Problem · 1

    IRN#: (B)(4). BROKEN HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840261 TUOHY NEEDLE EPIDURAL NEEDLE BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 1150-6K091 1353.10 14048223004019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other