BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INFUSION SET

    MDR report key: 14288983 · Received May 5, 2022

    Report

    Report Number
    2243072-2022-00617
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 17, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 27-APR-2022. H.6. INVESTIGATION: UNFORTUNATELY A LOT NUMBER COULD NOT BE SUBMITTED FOR THIS COMPLAINT, AND COULD NOT BE DETERMINED FROM THE PHOTOGRAPHS PROVIDED. PREVENTING OUR INVESTIGATION TEAM FROM CONDUCTING A DEVICE HISTORY REVIEW. ADDITIONALLY, A SAMPLE WAS RECEIVED FOR TO AID IN OUR INVESTIGATION. OUR ENGINEERS SUBJECTED THE RETURNED DEVICE TO HIGH PRESSURE FLUID TESTING WHILE THE TUBING WAS CLAMPED. DURING THE COURSE OF TESTING THE CLAMP WAS ABLE TO MAINTAIN A SEAL. FURTHER VISUAL OBSERVATION WAS CONDUCTED ON THE CLAMP COMPONENT, WHICH WAS UNABLE TO IDENTIFY ANY OBVIOUS ABNORMALITIES OR DEFORMITIES. FINALLY A DESTRUCTIVE DISSECTION OF THE TUBING WAS CONDUCTED TO ADEQUATELY MEASURE THE INTERIOR AND EXTERIOR DIAMETER OF THE TUBING AT MULTIPLE INTERSECTIONS. ALL TESTED SECTIONS RETURN VALUES THAT WERE WITHIN THE PRODUCT SPECIFICATIONS. UNFORTUNATELY, OUR ENGINEERS WERE NOT ABLE TO CONFIRM THE REPORTED NON-CONFORMANCE BASED ON THE AVAILABLE DATA. WITHOUT THE ABILITY TO REPLICATE THE REPORTED NON-CONFORMANCE OUR ENGINEERS WERE NOT ABLE TO DETERMINE A ROOT CAUSE FOR THIS EVENT. A TOTAL OF 60 RETAIN SAMPLES OF THE COMPLAINT PRODUCT (IV SET BN310 W/O BP Y-CONN, LOT NO. 2202071, 2202093, 2202141, 2202151, 2203042 & 2203221) WAS CHECKED AND THERE WAS NO DEFECTIVE PRODUCT FOUND IN THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ INFUSION SET WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DRUG FLOW THROUGHOUT IV SET WAS BLOCKED BY SOME ERRORS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ INFUSION SET WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DRUG FLOW THROUGHOUT IV SET WAS BLOCKED BY SOME ERRORS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692450 BD¿ INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown