BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD DEVICE

    MDR report key: 11963529 · Received June 8, 2021

    Report

    Report Number
    2243072-2021-01641
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 5, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT THE TUBING SPONTANEOUSLY BECAME DISCONNECTED AND BLOOD AND FLUIDS WERE LEAKING 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. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED WITHOUT A FAILURE INVESTIGATION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD DEVICE EXPERIENCED COMPONENT SEPARATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "G9- PATIENT IN THE PATC RECIEVING CHEMOTHERAPY. 1410: RN CALLED TO PATIENT'S ROOM. AT BEDSIDE, PATIENT'S MOTHER REPORTED THAT IV TUBING SPONTANEOUSLY BECAME DISCONNECTED AND SHE NOTICED BLOOD AND FLUIDS LEAKING ON TO THE PATIENT. UPON INSPECTION, RN NOTICED THAT THE OPTIMA CONNECTOR HAD BEEN DISCONNECTED FROM TUBING. UNKNOWN AMOUNT OF CHEMOTHERAPY LEAKED UP ONTO PATIENT'S BED AND LEGS. APP NOTIFIED. CHEMO SPILL KIT OBTAINED AND SPILL CLEANED PER PROTOCOL. PATIENT CLEANED AND MOTHER EDUCATED ON SIGNS AND SYMPTOMS OF SKIN IRRITATION RELATED TO CHEMOTHERAPY EXPOSURE. NEW TUBING OBTAINED. CHEMOTHERAPY BAG NOT CONTAMINATED. PER APP AND PRIMARY TEAM OKAY TO INFUSE REMAINDER OF THE BAG. NO RE-DOSE NECESSARY FOR CHEMOTHERAPY LOST, PER THE TEAM."

    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." MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, 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 COMPONENT SEPARATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: PATIENT IN THE PATC RECIEVING CHEMOTHERAPY. 1410: RN CALLED TO PATIENT'S ROOM. AT BEDSIDE, PATIENT'S MOTHER REPORTED THAT IV TUBING SPONTANEOUSLY BECAME DISCONNECTED AND SHE NOTICED BLOOD AND FLUIDS LEAKING ON TO THE PATIENT. UPON INSPECTION, RN NOTICED THAT THE OPTIMA CONNECTOR HAD BEEN DISCONNECTED FROM TUBING. UNKNOWN AMOUNT OF CHEMOTHERAPY LEAKED UP ONTO PATIENT'S BED AND LEGS. APP NOTIFIED. CHEMO SPILL KIT OBTAINED AND SPILL CLEANED PER PROTOCOL. PATIENT CLEANED AND MOTHER EDUCATED ON SIGNS AND SYMPTOMS OF SKIN IRRITATION RELATED TO CHEMOTHERAPY EXPOSURE. NEW TUBING OBTAINED. CHEMOTHERAPY BAG NOT CONTAMINATED. PER APP AND PRIMARY TEAM OKAY TO INFUSE REMAINDER OF THE BAG. NO RE-DOSE NECESSARY FOR CHEMOTHERAPY LOST, PER THE TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850515 UNSPECIFIED BD DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1