BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D 2SS CV

    MDR report key: 11009571 · Received December 15, 2020

    Report

    Report Number
    2243072-2020-02061
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 18, 2020
    Report Date
    January 18, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    37613203021020
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 11/25/2020 H.6. INVESTIGATION: A COMPLAINT OF DEFECTIVE TUBING WAS RECEIVED FROM THE CUSTOMER. ONE SAMPLE WAS RETURNED FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE SAMPLE, KINKS WERE FOUND ON THE TUBING BELOW THE ROLLER CLAMP AND AT THE CONNECTION OF THE FIRST Y-SITE. THE FIRST KINK COULD BE SMOOTHED OUT BUT THE KINK AT THE Y-SITE COULD NOT BE. THE DRIP CHAMBER WAS ALSO DISCONNECTED FROM THE REST OF THE SET. 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 FOR THESE DEFECTS WAS DETERMINED AS STERILIZING THE PRODUCT PRIOR TO THE SOLVENT CONNECTING THE TUBING FULLY DRYING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A AS LVP 20D 2SS CV HAD DEFECTIVE TUBING DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPOTER: "IT WAS REPORTED THAT TUBING WAS DEFECTIVE. VERBATIM: -> XXX, APPARENTLY HAD A PROBLEM WITH IV TUBING THAT WAS DEFECTIVE. CAN YOU COLLECT FROM HERE AND LET DAVE KNOW THE VENDOR AND THE MFG # AND SERIAL # SO HE CAN LET THE REP KNOW? XXXX CAN ASK THE REP TO SEND THE REPORT IN AFTER THE COMPANY REVIEWS AND COPY XXXX ON IT. HAVE A GOOD DAY! ->HELLO XXX, THE IV TUBING THAT WAS DEFECTIVE IS ITEM 0003545, SET INFUSION CK VALVE. REF. NUMBER 2420-0007. THIS WAS PURCHASED FROM MEDLINE NOT BD DIRECTLY I DON'T KNOW IF THAT WILL MAKE A DIFFERENCE. ALSO, THEY DID NOT SAVE THE PACKAGING SO I CAN NOT PINPOINT THE LOT NUMBER. I HAVE THE DEFECTIVE ITEM IN MY POSSESSION, WHEN READY TO SHIP TO BD PLEASE LET ME KNOW. HOPE THIS HELPS. LET ME KNOW IF YOU NEED MORE INFORMATION. ->XXXX, PLEASE SEE THE ATTACHED EMAIL REPORTING A PRODUCT FAILURE. PLEASE LET ME KNOW THE NEXT STEPS. THANK YOU, XXX.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 A AS LVP 20D 2SS CV HAD DEFECTIVE TUBING DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPOTER: "IT WAS REPORTED THAT TUBING WAS DEFECTIVE. VERBATIM: XXX, APPARENTLY HAD A PROBLEM WITH IV TUBING THAT WAS DEFECTIVE. CAN YOU COLLECT FROM HERE AND LET DAVE KNOW THE VENDOR AND THE MFG # AND SERIAL # SO HE CAN LET THE REP KNOW? XXXX CAN ASK THE REP TO SEND THE REPORT IN AFTER THE COMPANY REVIEWS AND COPY XXXX ON IT. HAVE A GOOD DAY! HELLO XXX, THE IV TUBING THAT WAS DEFECTIVE IS ITEM 0003545, SET INFUSION CK VALVE. REF. NUMBER (B)(4). THIS WAS PURCHASED FROM MEDLINE NOT BD DIRECTLY I DON'T KNOW IF THAT WILL MAKE A DIFFERENCE. ALSO, THEY DID NOT SAVE THE PACKAGING SO I CAN NOT PINPOINT THE LOT NUMBER. I HAVE THE DEFECTIVE ITEM IN MY POSSESSION, WHEN READY TO SHIP TO BD PLEASE LET ME KNOW. HOPE THIS HELPS. LET ME KNOW IF YOU NEED MORE INFORMATION. XXXX, PLEASE SEE THE ATTACHED EMAIL REPORTING A PRODUCT FAILURE. PLEASE LET ME KNOW THE NEXT STEPS. THANK YOU, XXX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479689 AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2420-0007 UNKNOWN 37613203021020

    Patients

    Seq Age Sex Outcome Treatment
    1