BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL 21X1-1/2 RB

    MDR report key: 10112386 · Received June 2, 2020

    Report

    Report Number
    1213809-2020-00359
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 12, 2020
    Report Date
    June 4, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095774
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY NO PHOTOS OR SAMPLES WERE RECEIVED FOR EVALUATION. THE BATCH NUMBERS PROVIDED: 4154804, 3298116, 0054508, 2150297, AND 3212011 WERE ALL MANUFACTURED PRIOR TO THE UDI REQUIREMENTS THAT MANDATED MARKING INDIVIDUAL PACKAGING WITH EXPIRATION DATE. THESE BATCHES WERE ALL MANUFACTURED CORRECTLY PER PRODUCT DESIGN AT THAT TIME. THE MOST RECENT BATCH, #4154804, WAS EXPIRED AS OF 31 MAY 2019. THE REPORTED DEFECT WAS NOT IDENTIFIED BASED ON THE PRODUCT INFORMATION PROVIDED AND NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 21X1-1/2 RB WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309577 BATCH NO. 2150297. IT WAS REPORTED THAT EXPIRATION DATE IS MISSING FROM SHELF CARTON.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. 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 · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 21X1-1/2 RB WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309577 BATCH NO. 2150297. IT WAS REPORTED THAT EXPIRATION DATE IS MISSING FROM SHELF CARTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571491 SYRINGE 3ML LL W/NDL 21X1-1/2 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309577 2150297 30382903095774

    Patients

    Seq Age Sex Outcome Treatment
    1 Other