BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 2ML

    MDR report key: 11773662 · Received May 4, 2021

    Report

    Report Number
    3002682307-2021-00170
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 6, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2011228. 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, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, THE SCALE MARKING WAS NOT LONG ENOUGH, CONFIRMING THE REPORTED DEFECT. THE PROCESS USED TO PRINT THE SCALE IS CALLED ¿HOT STAMPING.¿ A METAL STAMP IS HEATED AND INTERPOSES A SPECIAL BLACK PRINTING FOIL ONTO THE SYRINGE BY PRESSURE. THE SCALE IS THEN EMBEDDED INTO THE BARREL WALL. IT HAS BEEN CONCLUDED THAT THIS ISSUE WAS A CONSEQUENCE OF A DEFECTIVE FOIL REEL. THE FOIL DID NOT WORK AS EXPECTED AND WAS NOT PERFECTLY PLACED BETWEEN THE STAMP AND THE BARREL, CAUSING THE SCALE TO BE IMPROPERLY PRINTED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 2ML HAD VOLUMETRIC ACCURACY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT ¿ THE 0,5 ML MARK IS, IN COMPARISON TO CORRECTLY PRINTED SCALES, NOT ELONGATED, WHICH MAKES DRAWING UP THE VACCINE MORE DIFFICULT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2011228. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2020-11-10. MEDICAL DEVICE LOT #: 2101146. MEDICAL DEVICE EXPIRATION DATE: 2025-12-31. DEVICE MANUFACTURE DATE: 2021-01-05. INITIAL REPORTER PHONE#: (B)(6). INITIAL REPORTER FACILITY: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 2ML HAD VOLUMETRIC ACCURACY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT ¿ THE 0,5 ML MARK IS, IN COMPARISON TO CORRECTLY PRINTED SCALES, NOT ELONGATED, WHICH MAKES DRAWING UP THE VACCINE MORE DIFFICULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668387 SYRINGE S2 2ML SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1