BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH NEEDLE

    MDR report key: 10374101 · Received August 6, 2020

    Report

    Report Number
    3002682307-2020-00241
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 1, 2020
    Report Date
    August 26, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS COMPLETED FOR MATERIAL NUMBER 301948 AND LOT NUMBER 1905289. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, 20 RETAINED SAMPLES WERE EVALUATED BY OUR QUALITY TEAM AND THE REPORTED DEFECT WAS NOT OBSERVED. IN ORDER TO PREVENT THIS DEFECT FROM OCCURRING, THE ASSEMBLY PROCESS HAS DETECTION SYSTEMS TO INSPECT THE NEEDLES AND REJECTS ANY WITH BROKEN PARTS. IT IS POSSIBLE THAT THIS ISSUE MAY HAVE OCCURRED DUE TO CONDITIONS DURING TRANSPORT OF THE PRODUCT AFTER MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ 20 ML SYRINGE WITH NEEDLE EXPERIENCED A BROKEN NEEDLE THAT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS SUFFERING FROM BRONCHIAL PNEUMONIA. AT 14:00 ON (B)(6) 2020, THE DAY NURSE LI RONGHAO USED A 20ML DISPOSABLE STERILE SYRINGE FROM BD MEDICAL DEVICES (SHANGHAI) CO., LTD. TO DISPENSE THE 4 BEDS FOR THE INPATIENT. AFTER UNPACKING, IT WAS FOUND THAT THE 18G NEEDLE IN THE PACKAGING TAPE WAS BROKEN, AND IT WAS IMMEDIATELY REPLACED WITH A 20ML DISPOSABLE STERILE SYRINGE. THE TREATMENT WENT ON SUCCESSFULLY THAT DAY.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ 20 ML SYRINGE WITH NEEDLE EXPERIENCED A BROKEN NEEDLE THAT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS SUFFERING FROM BRONCHIAL PNEUMONIA. AT 14:00 ON (B)(6) 2020, THE DAY NURSE (B)(6) USED A 20 ML DISPOSABLE STERILE SYRINGE FROM BD MEDICAL DEVICES (B)(6) CO., LTD. TO DISPENSE THE 4 BEDS FOR THE INPATIENT. AFTER UNPACKING, IT WAS FOUND THAT THE 18 G NEEDLE IN THE PACKAGING TAPE WAS BROKEN, AND IT WAS IMMEDIATELY REPLACED WITH A 20 ML DISPOSABLE STERILE SYRINGE. THE TREATMENT WENT ON SUCCESSFULLY THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841443 BD 20 ML SYRINGE WITH NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1905289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other