BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10893005 · Received November 24, 2020

    Report

    Report Number
    3002682307-2020-00359
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    July 1, 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

    H.6. INVESTIGATION: 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 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 EXAMINED AND NO SIGNS OF FOREIGN MATTER OR DEFECT WERE OBSERVED. BASED ON THE INVESTIGATION FINDINGS, THIS EXACT CAUSE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA HAD FOREIGN MATTER IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INTRACRANIAL INFECTION OF HYDROCEPHALUS. AT 8:30 ON (B)(6) 2020, DAY NURSE USED A 20ML DISPOSABLE STERILE SYRINGE TO PREPARE TO DISPENSE MEDICINE FOR 16 BEDS OF INPATIENTS. IN THE PROCESS OF CHECKING THE 20ML DISPOSABLE STERILE SYRINGE, IT WAS FOUND THAT THERE WAS A BLACK FOREIGN MATTER IN THE PACKAGING, AND IMMEDIATELY REPLACED IT WITH A 20ML DISPOSABLE STERILE SYRINGE. THE PATIENT'S TREATMENT PROCEEDED SMOOTHLY 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 HAD FOREIGN MATTER IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INTRACRANIAL INFECTION OF HYDROCEPHALUS. AT 8:30, ON (B)(6) 2020, DAY NURSE USED A 20ML DISPOSABLE STERILE SYRINGE TO PREPARE TO DISPENSE MEDICINE FOR 16 BEDS OF INPATIENTS. IN THE PROCESS OF CHECKING THE 20ML DISPOSABLE STERILE SYRINGE, IT WAS FOUND THAT THERE WAS A BLACK FOREIGN MATTER IN THE PACKAGING, AND IMMEDIATELY REPLACED IT WITH A 20ML DISPOSABLE STERILE SYRINGE. THE PATIENT'S TREATMENT PROCEEDED SMOOTHLY THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354806 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1905289

    Patients

    Seq Age Sex Outcome Treatment
    1