BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH NEEDLE

    MDR report key: 7115865 · Received December 13, 2017

    Report

    Report Number
    2243072-2017-00397
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 20, 2017
    Report Date
    April 27, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903030201
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION INFORMATION ON "DATE RECEIVED BY MANUFACTURER:" THE FOLLOWING FIELD HAS BEEN UPDATED. DATE RECEIVED BY MANUFACTURER: 11/20/2017.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: ONE 3ML SYRINGE WITH NEEDLE AND OPEN CONVENIENCE PACK WAS RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7220010 (P/N 303020). A CRACK WAS OBSERVED BETWEEN APPROXIMATELY ½ ML TO THE 2ML MARKINGS. CRACKED BARREL IS A REJECTABLE CONDITION AS PER PRODUCT SPECIFICATION. A DEVICE HISTORY RECORD REVIEW FOR 3ML SYRINGE BATCH 7130877 (P/N 304740): BULK NON-STERILE AS WELL AS FOR FINISHED PRODUCT 3ML SYRINGE WITH 22GX1 NEEDLE LOT # 7220010 (P/N 303020) SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE EVALUATION PERFORMED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE AND CAPA NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT. 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.

    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. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH NEEDLE HAD A CRACK IN THE BARREL. FOUND DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891724 BD LUER-LOK¿ SYRINGE WITH NEEDLE HYPODERMIC SYRINGE AND NEEDLE FMF BECTON DICKINSON 7220010 30382903030201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other