BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18073050 · Received November 6, 2023

    Report

    Report Number
    3002682307-2023-00322
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 12, 2023
    Report Date
    March 22, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903019489
    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 HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4) AND LOT NUMBER 2110188. 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 WITHIN SPECIFICATIONS. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE (3) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, WHITE PARTICLES WERE OBSERVED IN THE SYRINGE. AN EXACT CAUSE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION RESULTS AT THIS TIME. ALTHOUGH THE HIGH-VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, BD KEEPS THE PARTICULATE MATTER TO EXTREMELY LOW LEVELS DUE TO THE STRINGENT PREVENTIVE MEASURES IN PLACE. WE ARE CONFIDENT THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. DEVICE RETURN NOT ANTICIPATED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE S2 20ML 18GA 1-1/2IN HAD DRUG PRECIPITATION IN THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE HEAD NURSE REPORTED THAT DURING THE DISPENSING PROCESS, DRUG PRECIPITATION WAS FOUND. THE AFFECTED QUANTITY WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131455 BD SYRINGE S2 20ML 18GA 1-1/2IN SYRINGE, PISTON FMF BECTON DICKINSON, S.A. 2110188 00382903019489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown