BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 7331759 · Received March 12, 2018

    Report

    Report Number
    9614033-2018-00010
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 15, 2018
    Report Date
    May 17, 2018
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE 3ML SYRINGE CONFIRMED TO BE FROM BATCH NUMBER UNKNOWN (P/N 309657) WAS RECEIVED AT BD FOR INVESTIGATION. VISUAL INSPECTION AND PRESSURE TEST FOR LEAKAGE WERE PERFORMED AND NO DEVIATION WAS FOUND. MOREOVER, ANALYSIS WERE DONE ON RETENTION SAMPLES TO ENSURE THE COMFORMITY OF THE PRODUCT, THESE WERE SATISFACTORY, NOT PRESENTING ANY PROBLEM ATTRIBUTABLE TO LEAKAGE. THIS IS THE 1ST RELATED COMPLAINT FOR LEAKAGE AT LUER CONNECTION ON THE TWO PROVIDED LOT NUMBERS (7171642, 7198658). A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A POSSIBLE ROOT CAUSE IS THE SYRINGE WAS NOT USED WITH THE RIGHT CONNECTOR. THERE IS NO ACTION PLAN AT THIS TIME SINCE THE DEFECT WAS NOT CONFIRMED. 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

    IT WAS REPORTED A 3 ML BD SYRINGE WITH BD LUER-LOK¿ TIP CONTAINING 0.5% MARCAINE LEAKED AT THE CONNECTION DURING USE. IN ADDITION, IT WAS REPORTED THE USER WAS EXPOSED TO THE MEDICATION AND THERE WAS A REOCCURRENCE OF THE EVENT. HOWEVER, THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175832 3 ML BD SYRINGE WITH BD LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON DE MEXICO SEE SECTION H.10. 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other