BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10900516 · Received November 25, 2020

    Report

    Report Number
    3002682307-2020-00366
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    July 30, 2020
    Report Date
    January 11, 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 1901183 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 UNAVAILABLE FOR RETURN, 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 DEFECTS WERE OBSERVED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUE TO ANAL FISTULA, THE PATIENT WAS USED A DISPOSABLE STERILE SYRINGE FOR DRUG INJECTION AT AROUND 09:00 ON(B)(6) 2020. AFTER THE PATIENT WAS EQUIPPED WITH ANTI-INFLAMMATORY DRUGS, HE FOUND THAT THE 20ML STERILE SYRINGE HAD NO THE TIP OF BARREL WHEN PREPARING THE MATERIAL. REPLACED IT IMMEDIATELY THE NEW 20ML STERILE SYRINGE DISPENSES MEDICATION FOR PATIENTS. THE TREATMENT WENT SUCCESSFULLY ON THE 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 (B)(6) WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUE TO ANAL FISTULA, THE PATIENT WAS USED A DISPOSABLE STERILE SYRINGE FOR DRUG INJECTION AT AROUND 09:00 ON (B)(6) 2020. AFTER THE PATIENT WAS EQUIPPED WITH ANTI-INFLAMMATORY DRUGS, HE FOUND THAT THE 20ML STERILE SYRINGE HAD NO THE TIP OF BARREL WHEN PREPARING THE MATERIAL. REPLACED IT IMMEDIATELY THE NEW 20ML STERILE SYRINGE DISPENSES MEDICATION FOR PATIENTS. THE TREATMENT WENT SUCCESSFULLY ON THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372124 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1901183

    Patients

    Seq Age Sex Outcome Treatment
    1