BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE¿ WITH NEEDLE

    MDR report key: 13048235 · Received December 20, 2021

    Report

    Report Number
    3002682307-2021-00665
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    October 28, 2021
    Report Date
    March 3, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301940 AND LOT NUMBER 1902137. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, RETAINED SAMPLES WERE OBTAINED FOR FURTHER EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETAINED SAMPLES, NO SIGNS OF DEFECT COULD BE OBSERVED. BASED ON THE LIMITED INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND IN THE BD SYRINGE¿ WITH NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "(B)(6) 2021, WHEN THE NURSE WAS DISPENSING MEDICINE FOR THE PATIENT, SHE TOOK A 2ML SYRINGE AND FOUND A WHITE LINEAR FOREIGN MATTER IN THE SYRINGE, WHICH WAS REPLACED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND IN THE BD SYRINGE¿ WITH NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "2021-10-28, WHEN THE NURSE WAS DISPENSING MEDICINE FOR THE PATIENT, SHE TOOK A 2ML SYRINGE AND FOUND A WHITE LINEAR FOREIGN MATTER IN THE SYRINGE, WHICH WAS REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945147 BD SYRINGE¿ WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1902137

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown