BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ PLUS WHITE BLEND

    MDR report key: 7110607 · Received December 12, 2017

    Report

    Report Number
    9610847-2017-00178
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 6, 2017
    Report Date
    February 22, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS OCCURRENCE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 7152548. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. CUSTOMER REPORTED LEAKAGE ISSUES; HOWEVER NO SAMPLE WAS AVAILABLE FOR EVALUATION. PRODUCT IS FUNCTIONAL TESTED AND NO INCIDENTS WITH LEAKAGES HAVE BEEN REPORTED. PROCESS FMEA RM5943 WAS REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. INVESTIGATION CONCLUSION: BASED ON INVESTIGATION RESULTS TO DATE, ROOT CAUSE FOR MANUFACTURING PROCESS CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD CONNECTA¿ PLUS WHITE BLEND LEAKED BETWEEN THE EXTENSION TUBE AND THE EXTRA VALVE DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890054 BD CONNECTA¿ PLUS WHITE BLEND STOP COCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7152548

    Patients

    Seq Age Sex Outcome Treatment
    1 Other