BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD TUBING

    MDR report key: 11838875 · Received May 17, 2021

    Report

    Report Number
    2243072-2021-01495
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    March 19, 2021
    Report Date
    May 31, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A COMPLAINT OF A SET NOT SELF- CLAMPING IN PUMP WAS RECEIVED FROM THE CUSTOMER. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF CLAMP ISSUES 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD¿ TUBING IV LINE WOULD NOT CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: UNKNOWN, BATCH/LOT #: UNKNOWN. IT WAS REPORTED THAT THE IV LINE WOULD NOT SELF-CLAMP TO PUMP. VERBATIM: AN IV LINE WAS BEING REMOVED FROM A CAREFUSION 303, INC. ALARIS PUMP. IT WAS NOTED THAT THE IV LINE WOULD NOT SELF-CLAMP TO THE PUMP, ALTHOUGH THE IV LINE WAS STILL CONNECTED TO THE PATIENT. PITOCIN BOLUSED FOR APPROXIMATELY 5 SECONDS. ACCORDING TO THE CLMICAL/BIOMEDICAL TEAM, WHEN THE OPERATOR FORCES THE LATCH TO CLOSE, IT CAN BREAK THE IV CLAMP AND MAY AFFECT PROPER INFUSING.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENTS AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. 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, (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. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 19 APRIL, 2021. MEDWATCH REPORT # (B)(4). REPORT SOURCE OTHER: MEDWATCH REPORT. 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" TUBING IV LINE WOULD NOT CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: UNKNOWN BATCH/LOT #: UNKNOWN. IT WAS REPORTED THAT THE IV LINE WOULD NOT SELF-CLAMP TO PUMP. VERBATIM: AN IV LINE WAS BEING REMOVED FROM A CAREFUSION 303, INC. ALARIS PUMP. IT WAS NOTED THAT THE IV LINE WOULD NOT SELF-CLAMP TO THE PUMP, ALTHOUGH THE IV LINE WAS STILL CONNECTED TO THE PATIENT. PITOCIN BOLUSED FOR APPROXIMATELY 5 SECONDS. ACCORDING TO THE CLMICAL/BIOMEDICAL TEAM, WHEN THE OPERATOR FORCES THE LATCH TO CLOSE, IT CAN BREAK THE IV CLAMP AND MAY AFFECT PROPER INFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734517 UNSPECIFIED BD TUBING INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR