BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL 120/PKG

    MDR report key: 12861483 · Received November 23, 2021

    Report

    Report Number
    3003152976-2021-00774
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 26, 2021
    Report Date
    December 17, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION?: YES. D9: RETURNED TO MANUFACTURER ON: 11/29/2021. H6: INVESTIGATION: TWO SAMPLES AND PHOTOS RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE SAMPLES RECEIVED IT CAN BE SEEN NO SCALE HAS BEEN PRINTED IN THE BARREL OF THE SYRINGES. A DEVICE HISTORY REVIEW WAS PERFORMED AND FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF LOT 2102013, ALL PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. POSSIBLE ROOT CAUSE, DUE TO A FAILURE IN THE TRIGGER THAT GUIDES THE BARREL TO BE CORRECTLY POSITIONED IN THE MOMENT OF SCALE TRANSFERENCE IN THE MARKING MACHINE. THIS FAILURE CAUSED A MISALIGNMENT CAUSING SCALE RESULTED COMPRESSED AND NOT PRINTED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. 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 · 0

    IT WAS REPORTED THAT BD SYRINGE 20ML LL 120/PKG HAD SCALE MARKING MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE WOULD LIKE TO INFORM YOU THAT WE HAVE FOUND 20 ML LUER LOCK SYRINGES (REF (B)(4)) WITHOUT GRADUATION".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 20ML LL 120/PKG HAD SCALE MARKING MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE WOULD LIKE TO INFORM YOU THAT WE HAVE FOUND 20 ML LUER LOCK SYRINGES (REF (B)(4)) WITHOUT GRADUATION ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757037 BD SYRINGE 20ML LL 120/PKG PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2102013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown