BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D DEHP 2SS CV

    MDR report key: 10856715 · Received November 17, 2020

    Report

    Report Number
    2243072-2020-01845
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 15, 2020
    Report Date
    December 22, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D1: MEDICAL DEVICE BRAND NAME: AS LVP 20D DEHP 2SS CV. D4: CATALOG # 2420-0500. D4: LOT # 20043252. D4: UDI # (B)(4). D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-11. G5 PMA / 510(K)#: K944320. H4: DEVICE MANUFACTURE DATE: 2020-04-25. H6: INVESTIGATION SUMMARY CUSTOMER REPORTED TUBING CAME APART AND RETURNED THE AFFECTED SAMPLE. THE SAMPLE CLEARLY SEPARATED AT THE OUTLET OF THE TOP PUMP CLIP AND THE COMPLAINT IS VERIFIED. DIMENSIONAL ANALYSIS WAS NOT ABLE TO CONDUCTED SINCE THE END OF THE TUBING WAS COMPROMISED. THIS IS A KNOWN ISSUE BY MANUFACTURING WITH A LOW OCCURRENCE RATE. THE FAILURE HAPPENS WHEN THE MANDRELS OF THE ASSEMBLY EQUIPMENT GET MISALIGNED AND THE SILICON IS TRAPPED UNDERNEATH. A VALIDATION PLAN WAS IMPLEMENTED 19MAY2020, AFTER THE LOT WAS MANUFACTURED 25APR2020. THIS ISSUE WILL BE PREVENTED MOVING FORWARD BECAUSE OF THE VALIDATION PLAN THAT WAS IMPLEMENTED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0500 LOT NUMBER 20043252 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 34,563 UNITS IN 1 LOT NUMBER WAS BUILT ON 25APR2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AS LVP 20D DEHP 2SS CV EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABOUT 30 MINUTES AGO I HAD A NURSE COME TO ME STATING THE IV TUBING HAD COME APART WHEN PRIMING A NEW BOTTLE OF PROPOFOL. THIS ISSUE APPEARS TO BE A BONDING ISSUE AND THE BLUE CAP THAT IS PLACED AT THE TOP OF THE ALARIS MODULE. THE TUBE DISCONNECTED FROM THE BLUE CONNECTION AND LOOKING IN THE TUBING IT APPEARS THE TUBING IS OCCLUDED WHICH LED TO THE DISCONNECTION.

    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. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD ALARIS TUBING SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABOUT 30 MINUTES AGO I HAD A NURSE COME TO ME STATING THE IV TUBING HAD COME APART WHEN PRIMING A NEW BOTTLE OF PROPOFOL. THIS ISSUE APPEARS TO BE A BONDING ISSUE AND THE BLUE CAP THAT IS PLACED AT THE TOP OF THE ALARIS MODULE. THE TUBE DISCONNECTED FROM THE BLUE CONNECTION AND LOOKING IN THE TUBING IT APPEARS THE TUBING IS OCCLUDED WHICH LED TO THE DISCONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322971 AS LVP 20D DEHP 2SS CV TUBING SET FPA BECTON DICKINSON 20043252

    Patients

    Seq Age Sex Outcome Treatment
    1