BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 9262666 · Received October 31, 2019

    Report

    Report Number
    9614033-2019-00267
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 16, 2019
    Report Date
    January 23, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096047
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS EXPIRED, THE MANUFACTURING PLANT IS UNABLE TO VERIFY. THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    MATERIAL NO: 309604; BATCH NO: 0162457. IT WAS REPORTED THAT BEFORE USE OF THE BD 10ML SYRINGE LUER-LOK¿ TIP THE SYRINGES WERE RECEIVED WITHOUT EXPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAVE BEEN MULTIPLE INSTANCES OF NOT HAVING AN EXPIRATION DATE ON THEIR FLUSH SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 309604 BATCH NO: 0162457. IT WAS REPORTED THAT BEFORE USE OF THE BD 10ML SYRINGE LUER-LOK¿ TIP THE SYRINGES WERE RECEIVED WITHOUT EXPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAVE BEEN MULTIPLE INSTANCES OF NOT HAVING AN EXPIRATION DATE ON THEIR FLUSH SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053269 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309604 0162457 30382903096047

    Patients

    Seq Age Sex Outcome Treatment
    1 Other