BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET

    MDR report key: 13563962 · Received February 18, 2022

    Report

    Report Number
    2243072-2022-00254
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 8, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    37613203021020
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE AS LVP 20D 2SS CV INTERVASCULAR ADMINISTRATION SET EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN NOTICED IV LINE INFUSING DOBUTAMINE WAS BROKEN PROXIMAL TO HUB D2: MEDICAL DEVICE BRAND NAME: AS LVP 20D 2SS CV D4: UDI # (B)(6) D4: MEDICAL DEVICE LOT #: 21105441 D4: MEDICAL DEVICE EXPIRATION DATE: 2024-10-07 H4: DEVICE MANUFACTURE DATE: 2021-10-07 D4: MEDICAL DEVICE LOT #: 21105521 D4: MEDICAL DEVICE EXPIRATION DATE: 2024-10-08 H4: DEVICE MANUFACTURE DATE: 2021-10-08 D4: MEDICAL DEVICE LOT #: 21105603 D4: MEDICAL DEVICE EXPIRATION DATE: 2024-10-08 H4: DEVICE MANUFACTURE DATE: 2021-10-08 D4: MEDICAL DEVICE LOT #: 21105448 D4: MEDICAL DEVICE EXPIRATION DATE: 2024-10-07 H4: DEVICE MANUFACTURE DATE: 2021-10-07 D4: MEDICAL DEVICE LOT #: 21105520 D4: MEDICAL DEVICE EXPIRATION DATE: 2024-10-08 H4: DEVICE MANUFACTURE DATE: 2021-10-08 D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-02-22 G.5. PMA / 510(K)#: K944320 H6: INVESTIGATION SUMMARY ONE SAMPLE WAS RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT OF COMPONENT DAMAGE WAS VERIFIED BY VISUAL INSPECTION. EVALUATION OF THE RECEIVED SAMPLE IDENTIFIED THAT THE TUBING SEPARATED FROM THE INLET PORT OF THE Y-SITE SMARTSITE BODY. FURTHER INVESTIGATION UNDER MAGNIFICATION INDICATES THAT THERE IS A LACK OF SOLVENT PRESENT ON THE Y-SITE SMARTSITE BODY AND THE INFUSION SET TUBING. THE CUSTOMER REPORTED THE MATERIAL NUMBER AND LOT NUMBER OF THE INFUSION SET TO BE, "UNKNOWN." INVESTIGATION OF THE SMARTSITE NUMBERS IDENTIFIED THE MATERIAL NUMBER TO BE 2420-0007 WITH THE FOLLOW POSSIBLE LOT NUMBERS: 21105441, 21105521, 21105603, 21105448 AND 21105520. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 21105441 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 07OCT2021. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 21105521 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 09OCT2021. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 21105603 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 08OCT2021. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 21105448 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 07OCT2021. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 21105520 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 08OCT2021. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE ROOT CAUSE FOR THE ISSUE SEEN IN THIS COMPLAINT IS A LACK OF SOLVENT APPLIED AT THE JOINT LOCATION OF THE Y-STIE SMARTSITE AND THE TUBING. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INTERVASCULAR ADMINISTRATION SET EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN NOTICED IV LINE INFUSING DOBUTAMINE WAS BROKEN PROXIMAL TO HUB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AS LVP 20D 2SS CV INTERVASCULAR ADMINISTRATION SET EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN NOTICED IV LINE INFUSING DOBUTAMINE WAS BROKEN PROXIMAL TO HUB

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2406511 UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2420-0007 SEE H10 37613203021020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown