BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ BAG ACCESS DEVICE

    MDR report key: 16773265 · Received April 19, 2023

    Report

    Report Number
    2243072-2023-00647
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 30, 2023
    Report Date
    June 13, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    KPE
    PMA / PMN Number
    K201936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GILERO LLC USA. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1., AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D.4 DEVICE EXPIRATION DATE: UNKNOWN. H.4 DEVICE MANUFACTURE DATE: UNKNOWN. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 00338 D4: MEDICAL DEVICE EXPIRATION DATE: 10-JAN-2025 H4: DEVICE MANUFACTURE DATE: 12-MAY-2022 H6: INVESTIGATION SUMMARY A COMPLAINT OF SET LEAKING DURING USE WAS RECEIVED FROM THE CUSTOMER. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF LEAKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. THE SUPPLIER OF THIS SET WAS NOTIFIED OF THE DEFECT. DEVICE HISTORY RECORD RESULTS COULD NOT BE OBTAINED FROM THE SUPPLIER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ BAG ACCESS DEVICE EXPERIENCED LEAKAGE. THIS IS 1 OF 5 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 OF OUR CADD PATIENTS HAD THEIR TUBING FALL OUT OF THEIR 5-FU BAGS. THE SPIKE ITSELF CAME OUT OF THE PORT. THIS IS THE FIRST WEEK WE HAVE STARTED TO REALLY USE THE NEW STYLE EMPTY BAG. IN ADDITION TO THE 2 ABOVE, ONE OF THE RN'S HAD A "PUMP OFF" TODAY AND WHILE REMOVING THE PUMP SHE NOTED HOW THE TUBING WOULD SPIN. THEY GAVE ME THIS BAG SO WE COULD SEE IT. IT'S INSIDE A CHEMO BAG ON THE COUNTER. FURTHER DISCUSSION WITH THE NURSES AND THEY SAID A PATIENT LAST WEEK NOTICED A LITTLE LEAKING FROM THEIR BAG. AT THE TIME THEY DIDN'T THINK MUCH OF IT. ANOTHER PATIENT WAS NOTED TO HAVE SOME WHITE "RESIDUE" WHEN THEY CAME FOR THEIR PUMP OFF. (B)(6) DID MENTION SHE NOTICED THE SPIKES GO IN THE BAG MUCH EASIER THAN THE OLDER STYLE BAG. SO PERHAPS THEY ARE COMING OUT EASIER TOO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ BAG ACCESS DEVICE EXPERIENCED LEAKAGE. THIS IS 1 OF 5 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 OF OUR CADD PATIENTS HAD THEIR TUBING FALL OUT OF THEIR 5-FU BAGS. THE SPIKE ITSELF CAME OUT OF THE PORT. THIS IS THE FIRST WEEK WE HAVE STARTED TO REALLY USE THE NEW STYLE EMPTY BAG. IN ADDITION TO THE 2 ABOVE, ONE OF THE RN'S HAD A "PUMP OFF" TODAY AND WHILE REMOVING THE PUMP SHE NOTED HOW THE TUBING WOULD SPIN. THEY GAVE ME THIS BAG SO WE COULD SEE IT. IT'S INSIDE A CHEMO BAG ON THE COUNTER. FURTHER DISCUSSION WITH THE NURSES AND THEY SAID A PATIENT LAST WEEK NOTICED A LITTLE LEAKING FROM THEIR BAG. AT THE TIME THEY DIDN'T THINK MUCH OF IT. ANOTHER PATIENT WAS NOTED TO HAVE SOME WHITE "RESIDUE" WHEN THEY CAME FOR THEIR PUMP OFF. XXXXX DID MENTION SHE NOTICED THE SPIKES GO IN THE BAG MUCH EASIER THAN THE OLDER STYLE BAG. SO PERHAPS THEY ARE COMING OUT EASIER TOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372020 BD SMARTSITE¿ BAG ACCESS DEVICE CONTAINER, I.V KPE BECTON DICKINSON 00338

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown