BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA

    MDR report key: 10902106 · Received November 25, 2020

    Report

    Report Number
    3002682307-2020-00369
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 29, 2020
    Report Date
    January 12, 2021
    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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1905289 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE NOT RETURNED FOR THIS ISSUE, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE INSPECTED AND NO SIGNS OF DEFECT WERE OBSERVED. BASED ON THE PROVIDED CUSTOMER FEEDBACK, THE REPORTED INCIDENT MOST LIKELY RESULTED FROM AN ERROR RELATED TO THE NEEDLE MANUFACTURING PROCESS; HOWEVER, WITH THE LIMITED INVESTIGATION FINDINGS, AN EXACT CAUSE COULD NOT BE CONFIRMED. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA NEEDLE WAS BROKEN. 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 OF LIU QIANMO 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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA NEEDLE WAS BROKEN. 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 20ML DISPOSABLE STERILE SYRINGE FROM BD MEDICAL DEVICES (B)(4) TO DISPENSE THE 4 BEDS OF (B)(6) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372223 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1905289

    Patients

    Seq Age Sex Outcome Treatment
    1