BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD IV TUBING

    MDR report key: 11758273 · Received April 30, 2021

    Report

    Report Number
    2243072-2021-01324
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    November 15, 2020
    Report Date
    May 27, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF IV TUBING DISCONNECTING AT THE PAC CONNECTION 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 VALID LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED WITHOUT A FAILURE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD¿ IV TUBING DISCONNECTED AND LEAKED CHEMO. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: UNKNOWN BATCH/ LOT #: UNKNOWN IT WAS REPORTED THAT THE IV TUBING DISCONNECTED CLOSE TO THE PAC CONNECTION, WHICH RESULTED IN CHEMO LEAKAGE. VERBATIM: PT. CALLED AND SAW THAT IV TUBING DISCONNECTED CLOSE TO THE PAC CONNECTION. NOTED SOME FEW DROPS OF CHEMO ON THE FLOOR APPROXIMATELY LESS THAN 5 ML. PAUSED ONGOING CHEMO, CLEANED THE AREA WITH CHEMO SPILL KIT CHANGE CAPS THEN RECONNECTED CHEMO. WILL INFORM ATTENDING MD.

    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 UNSPECIFIED BD¿ IV TUBING DISCONNECTED AND LEAKED CHEMO. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: UNKNOWN BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT THE IV TUBING DISCONNECTED CLOSE TO THE PAC CONNECTION, WHICH RESULTED IN CHEMO LEAKAGE. VERBATIM: PT. CALLED AND SAW THAT IV TUBING DISCONNECTED CLOSE TO THE PAC CONNECTION. NOTED SOME FEW DROPS OF CHEMO ON THE FLOOR APPROXIMATELY LESS THAN 5 ML. PAUSED ONGOING CHEMO, CLEANED THE AREA WITH CHEMO SPILL KIT CHANGE CAPS THEN RECONNECTED CHEMO. WILL INFORM ATTENDING MD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647843 UNSPECIFIED BD IV TUBING INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1