BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 21G 1IN

    MDR report key: 18360165 · Received December 19, 2023

    Report

    Report Number
    2243072-2023-02214
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 21, 2023
    Report Date
    January 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903020158
    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

    BASED ON DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCH. THE TOPWEB UNIT PACKAGE ATTACHED TO THE IN-PROCESS INSPECTION FORM, MFG-003/L HAD SHOWN THAT THE VARIABLE PRINT DETAILS WERE PRESENT DURING THE START SHIFT INSPECTION. THERE IS A VISUAL INSPECTION TO CHECK FOR MISSING VARIABLE PRINTING GRAPHIC AT THE QA OUTGOING INSPECTION PER MQA-013/C WITH NO ABNORMALITY OBSERVED DURING THE INSPECTION. THE PRIMARY PACKAGING PROCESS WAS RECEIVED. PROBABLE ROOT CAUSE COULD BE THAT THE CABLE FOR THE PRINTER WORN OFF DUE TO CONSTANT RUBBING (TO & FRO) MOTION RESULTED IN SIGNAL LOST DURING PRINTING PROCESS AND THUS CAUSING MISSING VARIABLE PRINT. ACTION HAD BEEN TAKEN TO CHANGE ALL CABLES TO DRAG CHAIN CABLE TO ELIMINATE WEAR AND TEAR DUE TO RUBBING (TO & FRO) MOTION ON JAN 2023. THERE WERE NO SIMILAR COMPLAINTS FROM OTHER CUSTOMER ON THE REPORTED BATCH 2346288. THIS COULD BE AN ISOLATED CASE WHERE ONLY 1 STRIP WAS AFFECTED. THE COMPLAINT TREND WILL BE TRACKED AND MONITORED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    BD DISPOSABLE NEEDLES 21G - LOT NUMBER NOT PRINTED ON 3 UNITS. BATCH NUMBER NOT PRINTED. SAMPLE PICS ATTACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE 21G 1IN LABEL CONTENT WAS MISSING THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; BD DISPOSABLE NEEDLES 21G - LOT NUMBER NOT PRINTED ON 3 UNITS. BATCH NUMBER NOT PRINTED. SAMPLE PICS ATTACHED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118082 BD NEEDLE 21G 1IN NEEDLE FMI BECTON DICKINSON 2346288 30382903020158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown