BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 22GA 1-1/4IN

    MDR report key: 12618982 · Received October 12, 2021

    Report

    Report Number
    3002682307-2021-00547
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    August 27, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-24. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301942 AND LOT NUMBER 2010170. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETURNED SAMPLES, LEAKAGE COULD NOT BE CONFIRMED. TWENTY ADDITIONAL RETAINED SAMPLES WERE OBTAINED FOR FURTHER EVALUATION. THE RETAINED SAMPLES DID NOT SHOW ANY SIGNS OF DEFECT. BASED ON THE INVESTIGATION RESULTS AND THE PROVIDED FEEDBACK, IT IS POSSIBLE THAT THE REPORTED INCIDENT RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED 301 SYRINGE S2 5ML 22GA 1-1/4IN HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: " OCCURRED IN THE REPRODUCTIVE DEPARTMENT, THE SYRINGE LEAKED DURING USE."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#:(B)(6). 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 301 SYRINGE S2 5ML 22GA 1-1/4IN HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): " OCCURRED IN THE REPRODUCTIVE DEPARTMENT, THE SYRINGE LEAKED DURING USE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511511 SYRINGE S2 5ML 22GA 1-1/4IN PISTON SYRINGE FMI BECTON DICKINSON, S.A. 2010170

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown