BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS LVP 20D 2SS CV

    MDR report key: 10694558 · Received October 17, 2020

    Report

    Report Number
    2243072-2020-01670
    Event Type
    Injury
    Date Received
    October 17, 2020
    Date of Event
    September 18, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AS LVP 20D 2SS CV BALLOONED AND WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THAT BD IV TUBING BALLOONED. PER CUSTOMER EMAIL: DISCUSSED THIS AT THEIR FACILITY ON THE 18TH, HAS TUBING IN HAND JUST TODAY TO KEEP FOR RETURN. TUBING BALLOONED OUT BETWEEN TWO CHAMBERS THAT GO INTO PUMP MODULE; WAS DISCOVERED WHILE IN THE PUMP; IT WAS OCCLUDED WITH PUMP ALARM BUT IT DID NOT SEPARATE OR LEAK. D.1. MEDICAL DEVICE BRAND NAME: AS LVP 20D 2SS CV D.4. MEDICAL DEVICE CATALOG #: 2420-0007 D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4) G.5. PMA / 510(K)#: K944320 H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED FOR INVESTIGATION BY THE CUSTOMER. IT WAS REPORTED THAT BD IV TUBING BALLOONED. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS PRIMED, AND THEN INFUSED WITH THE PUMP DCHU-0009 AND PUMP MODULE DCHU-0015 AT 100 ML / HR. NO BALLOONING OCCURRED THROUGHOUT THE INFUSION, OR AFTER THE INFUSION. THE COMPLAINT COULD NOT BE VERIFIED AND THE FAILURE WAS UNABLE TO BE REPLICATED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2420-0007 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED BECAUSE THE FAILURE WAS UNABLE TO BE REPLICATED. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS LVP 20D 2SS CV BALLOONED AND WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THAT BD IV TUBING BALLOONED. PER CUSTOMER EMAIL: DISCUSSED THIS AT THEIR FACILITY ON THE 18TH, HAS TUBING IN HAND JUST TODAY TO KEEP FOR RETURN. TUBING BALLOONED OUT BETWEEN TWO CHAMBERS THAT GO INTO PUMP MODULE; WAS DISCOVERED WHILE IN THE PUMP; IT WAS OCCLUDED WITH PUMP ALARM BUT IT DID NOT SEPARATE OR LEAK.

    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 IN AND THE FRANKLIN LAKES 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ TUBING BALLOONED AND WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THAT BD IV TUBING BALLOONED. PER CUSTOMER EMAIL: DISCUSSED THIS AT THEIR FACILITY ON THE 18TH, HAS TUBING IN HAND JUST TODAY TO KEEP FOR RETURN. TUBING BALLOONED OUT BETWEEN TWO CHAMBERS THAT GO INTO PUMP MODULE; WAS DISCOVERED WHILE IN THE PUMP; IT WAS OCCLUDED WITH PUMP ALARM BUT IT DID NOT SEPARATE OR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159365 AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other