BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 7283049 · Received February 20, 2018

    Report

    Report Number
    1213809-2018-00046
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    January 23, 2018
    Report Date
    April 2, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE LOTS WERE MANUFACTURED BOTH IN LINE 2 FOR TWO DAYS, DURING 5 AND 6 SHIFTS RESPECTIVELY, THE PRODUCTION WAS MONITORED THROUGH THE FREQUENCY RIT0225CTIS01-04 REV.17, WHERE THEY EVALUATED CHARACTERISTICS AT EACH STAGE OF THE MANUFACTURING PROCESS WITH CONFORMING RESULTS. PLEASE NOTE THAT THE BATCHES PRODUCED IN THE PLANT ARE WITHOUT ASSEMBLED OR ATTACHED NEEDLE. ADDITIONALLY, IN THE DOCUMENTARY REVIEW, THERE WERE NO PROBLEMS ATTRIBUTABLE TO THE DEFECT, ADDITIONAL INSPECTIONS IN PROCESS AND TESTS IN FINAL PRODUCT WERE IN CONFORMANCE. ALSO, IN THE TESTS OF THE RETENTION SAMPLES, RESULTS WERE PRESENTED IN ACCORDANCE. THE LUER-LOK DESIGN HAS A ROPE AROUND THE PIVOT THAT ALLOWS YOU TO SCREW AND SECURE THE NEEDLE PERFECTLY, IT IS COMPATIBLE WITH ALL BD HYPODERMIC NEEDLES, THEREFORE, IT IS SUGGESTED TO USE BD WRINKLES AND FOR THE APPROPRIATE MEDICATION AS INDICATED IN THE IMAGE, SINCE IT IS UNKNOWN WHAT TYPE OF CONNECTOR WAS USED BECAUSE THERE IS NO SAMPLE OR PHOTOGRAPH FOR A BETTER EVALUATION. THEREFORE, THE CLAIM IS RULED UNCONFIRMED. 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

    TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 7171642, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30,  DEVICE MANUFACTURE DATE: 2017-08-01. MEDICAL DEVICE LOT #: 7198658, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2017-10-04. 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

    CLINICAL STAFF REPORTED THAT A 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP WAS FOUND LEAKING AT THE CONNECTION DURING USE. THE SYRINGE CONTAINED EPINEPHRINE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125693 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10. 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1 Other