BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PR CLEAR SSL NVS STEIN

    MDR report key: 8675989 · Received June 6, 2019

    Report

    Report Number
    3001741852-2019-00012
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    May 21, 2019
    Report Date
    October 11, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWO (2) PICTURES WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS CONFIRMS THE PROBLEM REPORTED BY THE CUSTOMER BECAUSE THE COC TRANSMITTED WAS NOT IN AGREEMENT WITH THE SHIPPED BATCH. INCORRECT BATCH NUMBER WAS ASSIGNED TO THIS BATCH IN BDM-PS INTERNAL SYSTEM DUE TO AN OVERSIGHT FROM THE OPERATOR. THIS ISSUE IS CONSIDERED AS AN ISOLATED EVENT. NEVERTHELESS, BDM-PS CONFIRMS THAT EXPIRY DATE IS SIMILAR ON COC AND LABEL, AND CONFORM TO THE SPECIFICATION FOR THE BATCH 1805122-1 INVOLVED IN THIS COMPLAINT. CORRECT COC FOR THE BATCH 1805122-1 WAS ATTACHED TO THE INTERIM REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INCORRECT EXPIRATION DATE WAS FOUND WITH A ULTRASAFE X100L PR CLEAR SSL NVS STEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING BATCH RECORD REVIEW OF MN:2031984 BN:180522-1 IT WAS NOTICED THAT THE EXPIRE DATE OF COA (2023/09/27) IS DIFFERENT TO THE ONE WHICH IS PRINTED ON THE SAMPLE CONTAINING BOX (2023/12/11). EXPIRE DATE OF SAMPLE BOX LABEL DOESN`T COMPLY TO EXPIRE DATE ON COA."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THAT INCORRECT EXPIRATION DATE WAS FOUND WITH A ULTRASAFE X100L PR CLEAR SSL NVS STEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING BATCH RECORD REVIEW OF MN:2031984 BN:180522-1 IT WAS NOTICED THAT THE EXPIRE DATE OF COA (2023/09/27) IS DIFFERENT TO THE ONE WHICH IS PRINTED ON THE SAMPLE CONTAINING BOX (2023/12/11). EXPIRE DATE OF SAMPLE BOX LABEL DOESN`T COMPLY TO EXPIRE DATE ON COA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467404 ULTRASAFE X100L PR CLEAR SSL NVS STEIN SYRINGE FMF BECTON DICKINSON 1805122-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other