BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML

    MDR report key: 8663611 · Received June 3, 2019

    Report

    Report Number
    3002682307-2019-00339
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 5, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. DRAWING AIR ON THE PLUNGER IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE SYRINGE S2 20ML THE SYRINGE IS DRAWING AIR ON THE PLUNGER LIQUID PASSES THROUGH THE PLUNGER. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: SYRINGE IS DRAWING AIR, PROBABLY ON THE STAMP; LIQUID / PROPOFOL PASSES THE STAMP, IT CAN NOT BE GUARANTEED THAT THE PATIENT GETS THE CORRECT AMOUNT OF MEDICATION.

    Additional Manufacturer Narrative · 1

    (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1901128. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2019-01-08. MEDICAL DEVICE LOT #: 1902139. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-01-29. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE...

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE SYRINGE S2 20ML THE SYRINGE IS DRAWING AIR ON THE PLUNGER LIQUID PASSES THROUGH THE PLUNGER. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: SYRINGE IS DRAWING AIR, PROBABLY ON THE STAMP; LIQUID / PROPOFOL PASSES THE STAMP, IT CAN NOT BE GUARANTEED THAT THE PATIENT GETS THE CORRECT AMOUNT OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458441 SYRINGE S2 20ML SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other