BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD DEVICE

    MDR report key: 11890328 · Received May 26, 2021

    Report

    Report Number
    2243072-2021-01543
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 27, 2021
    Report Date
    June 9, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THERE ARE SMALL BUBBLES IN THE TUBING THAT ALERTS "AIR IN LINE" IN THE PUMP. THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD DEVICE EXPERIENCED AIR IN THE LINE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "WE HAVE RECEIVED MULTIPLE INQUIRIES FROM INFUSION NURSING ACROSS LCI WITH REGARDS TO AIR IN LINE ALARMS ON THE PUMPS HAPPENING WITH THE MEDICATION FOSAPREPITANT. FOR THIS PARTICULAR MEDICATION, PHARMACY ADMIXES IT IN A 250 ML BAG, SENDS TO INFUSION, NURSING PRIMES THE LINE AND AFTER STARTING THE INFUSION THERE ARE SMALL LITTLE BUBBLES THAT ARE FORMING CAUSING AIR IN LINE ALERTS ON THE PUMP."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD DEVICE EXPERIENCED AIR IN THE LINE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "WE HAVE RECEIVED MULTIPLE INQUIRIES FROM INFUSION NURSING ACROSS LCI WITH REGARDS TO AIR IN LINE ALARMS ON THE PUMPS HAPPENING WITH THE MEDICATION FOSAPREPITANT. FOR THIS PARTICULAR MEDICATION, PHARMACY ADMIXES IT IN A 250 ML BAG, SENDS TO INFUSION, NURSING PRIMES THE LINE AND AFTER STARTING THE INFUSION THERE ARE SMALL LITTLE BUBBLES THAT ARE FORMING CAUSING AIR IN LINE ALERTS ON THE PUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786169 UNSPECIFIED BD DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1