BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II - 2-PIECE SYRINGE

    MDR report key: 13533999 · Received February 15, 2022

    Report

    Report Number
    2243072-2022-00208
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    February 1, 2022
    Report Date
    March 25, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS BAWAL IS AN OEM MANUFACTURING SITE. 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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿PACKAGING DAMAGED¿ WITH LOT NUMBER 0242834 REGARDING ITEM # 301866, SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE INVESTIGATION AND SIMULATION WAS CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES AND NO DAMAGED PACKAGING WAS FOUND IN THE TEN RETENTION SAMPLES. AS NO SAMPLE OR PHOTOGRAPHS ARE AVAILABLE THE INVESTIGATION TEAM COULD NOT CONFIRM THE REPORTED DEFECT OF DAMAGED PACKAGING. TO CONFIRM THE DEFECT AND TO INVESTIGATE THE ROOT CAUSE THE ORIGINAL SAMPLE WILL BE REQUIRED. THE DEFECT IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II - 2-PIECE SYRINGE HAD PACKAGE SEAL ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONLINE REJECTION FOR BLACK SPOTS AND BLISTER LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II - 2-PIECE SYRINGE HAD PACKAGE SEAL ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONLINE REJECTION FOR BLACK SPOTS AND BLISTER LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585851 BD DISCARDIT¿ II - 2-PIECE SYRINGE INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 0242834

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown