BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 20ML

    MDR report key: 12666482 · Received October 20, 2021

    Report

    Report Number
    3002682307-2021-00563
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    September 20, 2021
    Report Date
    November 2, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-10-05. INVESTIGATION SUMMARY: THE AFFECTED SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. AFTER EVALUATION, THE TEAM WAS ABLE TO CONFIRM THE REPORTED ISSUE, AND CONCLUDED THAT THE PARTICLES INSIDE THE SYRINGE WERE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS ISOLATED AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS AS THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT, AND CONSIDERING THE IN-COMING AND IN-PROCESS INSPECTION. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE S2 20ML, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA. THIS EVENT OCCURRED TEN TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WHILE PREPARING AND WITHDRAWING AQUA STERIL AND CEFUROXIM 1,5 G ANTIBOITIC INTO A DISCARDIT 20 ML SYRINGE, IT WAS NOTED THAT BLACK FLAKES APPEARED IN THE SYRINGE ONCE THE FLUID WAS IN THE SYRINGE. THE AFFECTED PRODUCT SAMPLES CONTAMINATED ARE AVAILABLE FOR INVESTIGATION ALTOGETHER 10 UNITS.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2105148 . MEDICAL DEVICE EXPIRATION DATE: 2026-04-30. DEVICE MANUFACTURE DATE: 2021-04-30. MEDICAL DEVICE LOT #: 2002189. MEDICAL DEVICE EXPIRATION DATE: 2025-01-31. DEVICE MANUFACTURE DATE: 2020-02-06. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD SYRINGE S2 20ML, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA. THIS EVENT OCCURRED TEN TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WHILE PREPARING AND WITHDRAWING AQUA STERIL AND CEFUROXIM 1,5 G ANTIBIOTIC INTO A DISCARDIT 20 ML SYRINGE, IT WAS NOTED THAT BLACK FLAKES APPEARED IN THE SYRINGE ONCE THE FLUID WAS IN THE SYRINGE. THE AFFECTED PRODUCT SAMPLES CONTAMINATED ARE AVAILABLE FOR INVESTIGATION ALTOGETHER 10 UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564721 BD SYRINGE S2 20ML PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown