BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE NS 1ML LS

    MDR report key: 10910070 · Received November 26, 2020

    Report

    Report Number
    3003152976-2020-00528
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    November 3, 2020
    Report Date
    December 4, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE LABEL WAS OBSERVED AND VERIFIED TO CONTAIN ALL PROPER INFORMATION. LABELING FOR THE PRODUCT DID NOT CONTAIN CE MARKING UNTIL (B)(6) 2020 WHEN THE CE MARKING WAS VALIDATED, LOT 2004050 WAS MANUFACTURED PRIOR TO THIS IMPLEMENTATION. BASED ON OUR INVESTIGATION, NO PRODUCT DEFECT WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE NS 1ML LS WAS MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION: I AM CONTACTING BD TO INFORM THEM THAT YESTERDAY WE RECEIVED A BATCH OF BD REF. 300328, BUT THE BATCH WE RECEIVED DOES NOT HAVE CE MARKING. WE NEED THE PRODUCT TO HAVE CE MARKING SO THAT WE CAN INCLUDE THEM IN OUR CUSTOM PACKS. I WOULD LIKE YOU TO TELL US WHAT OPTIONS THERE ARE TO SOLVE THIS INCIDENT, FOR EXAMPLE IF YOU RETURN THIS BATCH AND RECEIVE ANOTHER THAT DOES HAVE CE MARKING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE NS 1ML LS WAS MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION: I AM CONTACTING BD TO INFORM THEM THAT YESTERDAY WE RECEIVED A BATCH OF BD REF. 300328, BUT THE BATCH WE RECEIVED DOES NOT HAVE CE MARKING. WE NEED THE PRODUCT TO HAVE CE MARKING SO THAT WE CAN INCLUDE THEM IN OUR CUSTOM PACKS. I WOULD LIKE YOU TO TELL US WHAT OPTIONS THERE ARE TO SOLVE THIS INCIDENT, FOR EXAMPLE IF YOU RETURN THIS BATCH AND RECEIVE ANOTHER THAT DOES HAVE CE MARKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377752 SYRINGE NS 1ML LS SYRINGE FMF BECTON DICKINSON, S.A. 2004050

    Patients

    Seq Age Sex Outcome Treatment
    1