BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AS LVP 20D 2SS CV

    MDR report key: 15254885 · Received August 18, 2022

    Report

    Report Number
    2243072-2022-01374
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    April 11, 2022
    Report Date
    January 17, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    37613203021020
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHILE USING THE BD AS LVP 20D 2SS CV THE SET LEAKED AT PUMP SEGMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCOUNT REPORTED ALARIS PRIMARY SET LEAKED AT PUMP SEGMENT, THEY HAVE ORIGINAL SAMPLE TO SEND BACK. D1: MEDICAL DEVICE BRAND NAME: BD AS LVP 20D 2SS CV; D4: UDI #: (B)(4); D4: CATALOG #: 2420-0007; D4: MEDICAL DEVICE LOT #: 21115698; D4: MEDICAL DEVICE EXPIRATION DATE: 11NOV2024; H4: DEVICE MANUFACTURE DATE: 11NOV2021. D4: MEDICAL DEVICE LOT #: 21115752; D4: MEDICAL DEVICE EXPIRATION DATE: 12NOV2024; H4: DEVICE MANUFACTURE DATE: 12NOV2021. D4: MEDICAL DEVICE LOT #: 21115748; D4: MEDICAL DEVICE EXPIRATION DATE: 11NOV2024; H4: DEVICE MANUFACTURE DATE: 11NOV2021. D4: MEDICAL DEVICE LOT #: 21115749; D4: MEDICAL DEVICE EXPIRATION DATE: 12NOV2024; H4: DEVICE MANUFACTURE DATE: 12NOV2021. D4: MEDICAL DEVICE LOT #: 21115752; D4: MEDICAL DEVICE EXPIRATION DATE: 12NOV2024; H4: DEVICE MANUFACTURE DATE: 12NOV2021. D4: MEDICAL DEVICE LOT #: 21115844; D4: MEDICAL DEVICE EXPIRATION DATE: 12NOV2024; H4: DEVICE MANUFACTURE DATE: 12NOV2021. G.5. PMA / 510(K)#: K944320. H6: INVESTIGATION SUMMARY: A SAMPLE WAS RECEIVED AND TESTED BY OUR QUALITY TEAM. THE CUSTOMER'S COMPLAINT OF LEAKAGE WAS CONFIRMED UPON INFUSION WITH SALINE AND THE COMPLAINT HAS BEEN VERIFIED. UNDER VISUAL ANALYSES USING MICROSCOPE, THE LEAK WAS COMING FROM A PINHOLE IN THE SILICONE PORTION OF TUBING WHICH IS TO BE INSERTED INTO PUMP. THE MANUFACTURER OF THIS INFUSION DEVICE HAS BEEN NOTIFIED AND AFTER FURTHER INVESTIGATION, THE PINHOLE IS DUE TO IMPROPER USE OF FIXTURES WHEN JOINING THIS PART OF TUBING WITH THE REST OF SET. QUALITY ALERTS HAVE BEEN ISSUED AND THE MANUFACTURER IS WORKING TO ELIMINATE FURTHER OCCURRENCES OF THIS FAILURE. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBERS: 21115698 ((B)(4) UNITS PRODUCED ON 11NOV2021), 21115752 ((B)(4) UNITS PRODUCED ON 12NOV2021), 21115748 ((B)(4) UNITS PRODUCED ON 11NOV2021), 21115749 ((B)(4) UNITS PRODUCED ON 12NOV2021), 21115752 ((B)(4) UNITS PRODUCED ON 12NOV2021), 21115844 ((B)(4) UNITS PRODUCED ON 12NOV2021) WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE BUILD OF THESE SETS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE UNSPECIFIED ALARIS¿ PUMP PRIMARY SET THE SET LEAKED AT PUMP SEGMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCOUNT REPORTED ALARIS PRIMARY SET LEAKED AT PUMP SEGMENT, THEY HAVE ORIGINAL SAMPLE TO SEND BACK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD AS LVP 20D 2SS CV THE SET LEAKED AT PUMP SEGMENT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCOUNT REPORTED ALARIS PRIMARY SET LEAKED AT PUMP SEGMENT, THEY HAVE ORIGINAL SAMPLE TO SEND BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791412 BD AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2420-0007 22085071 37613203021020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown