BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ AN122 IV PUMP SET

    MDR report key: 13759263 · Received March 14, 2022

    Report

    Report Number
    2243072-2022-00339
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 22, 2022
    Report Date
    April 21, 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. DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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: 25-FEB-2022. H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2001151. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY A SAMPLE WAS RETURNED TO OUR FACILITY TO AID IN OUR INVESTIGATION. OUR ENGINEERS INSPECTED THE DEVICE FOR COMPLIANCE TO TUBING WIDTH SPECIFICATIONS, AND FUNCTIONALLY TESTED THE DEVICE TO SEE IF EXCESS FLUID WAS DELIVERED UNDER NORMAL PRODUCT SPECIFICATIONS. OUR ENGINEERS FOUND THE DIAMETER OF THE INNER TUBING WALL TO CONFORM TO SPECIFICATIONS, AND WERE UNABLE TO DETECT EXCESS FLUID WHILE PUMPING UNDER EXPECTED OPERATION LIMITS. BASED ON THE RESULTS OF THIS INVESTIGATION OUR ENGINEERS WERE NOT ABLE TO ASSOCIATE THIS ISSUE WITH THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 960 BD¿ AN122 IV PUMP SETS OVER-INFUSED MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN USED FOR THE IV SET PUMP, EXCESSIVE MEDICINE INJECTION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 960 BD¿ AN122 IV PUMP SETS OVER-INFUSED MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN USED FOR THE IV SET PUMP, EXCESSIVE MEDICINE INJECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279373 BD¿ AN122 IV PUMP SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2001151

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown