BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 8544383 · Received April 24, 2019

    Report

    Report Number
    1213809-2019-00470
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 9, 2019
    Report Date
    May 31, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095798
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS COMPLAINT IS A SERVICE COMPLAINT AND NOT A PRODUCT COMPLAINT. COMPLAINT TO BE CANCELLED AS A PRODUCT COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE WAS RECEIVED DAMAGED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309579 BATCH NO.: 8329717. IT WAS REPORTED THE PRODUCT WAS RECEIVED DAMAGED. VERBATIM: PRODUCT IS DAMAGED/LEAKING/OUTDATED. PLEASE LET US KNOW IF A CALL TAG WILL BE ISSUED OR IF YOU WOULD LIKE US TO DESTROY OR DONATE THE PRODUCT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. 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 BD LUER-LOK¿ SYRINGE WAS RECEIVED DAMAGED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309579, BATCH NO.: 8329717. IT WAS REPORTED THE PRODUCT WAS RECEIVED DAMAGED. VERBATIM: PRODUCT IS DAMAGED/LEAKING/OUTDATED. PLEASE LET US KNOW IF A CALL TAG WILL BE ISSUED OR IF YOU WOULD LIKE US TO DESTROY OR DONATE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338023 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8329717 30382903095798

    Patients

    Seq Age Sex Outcome Treatment
    1 Other