BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ SECONDARY SET C61

    MDR report key: 17726097 · Received September 11, 2023

    Report

    Report Number
    2243072-2023-01620
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    August 26, 2023
    Report Date
    January 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    UDI-DI
    00382905153020
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT 515302, LOT 1024992, QTY 20.160, PRODUCED OCTOBER 2022. MANUFACTURING PROCESS WAS CONDUCTED IN ACCORDANCE WITH DOCUMENT (B)(4) AND ALL QUALITY CONTROL ACTIVITIES HAVE BEEN PERFORMED ACCORDING TO QUALITY SPECIFICATION (B)(4) AND (B)(4). ACCORDING TO DHR, THERE WERE NO QUALITY NOTIFICATIONS OBSERVED DURING MANUFACTURING PROCESS RELATED TO CUSTOMER COMPLAINT. AFTER DETAILED INVESTIGATION, IT CAN BE SAID THAT THERE IS ONE POTENTIAL ROOT CAUSE WHICH COULD BE CONNECTED WITH PACKAGING PROCESS OF SUBJECT PRODUCT. DURING SEALING PROCESS THERE COULD HAPPEN THAT PACKAGING MACHINE SLICED THE INFUSION SET.. THIS BATCH HAVE BEEN PACKED AT PACKAGING MACHINE MULTIVAC IDN 373. IF CUSTOMER PROVIDE ADDITIONAL INFORMATION THAT COULD HELP TO CONDUCT MORE DETAIL INVESTIGATION, INVESTIGATION OF THIS CUSTOMER COMPLAINT WILL BE REVISED, AS NEEDED.

    Additional Manufacturer Narrative · 0

    PRODUCT 515302, LOT 1024992, QTY 20.160, PRODUCED OCTOBER 2022. MANUFACTURING PROCESS WAS CONDUCTED IN ACCORDANCE WITH DOCUMENT 15-0137 AND ALL QUALITY CONTROL ACTIVITIES HAVE BEEN PERFORMED ACCORDING TO QUALITY SPECIFICATION 10-0160 AND 10-0255. ACCORDING TO DHR, THERE WERE NO QUALITY NOTIFICATIONS OBSERVED DURING MANUFACTURING PROCESS RELATED TO CUSTOMER COMPLAINT. PHOTOGRAPHS PROVIDED DISPLAYING FLATTENED TUBING. AFTER DETAILED INVESTIGATION, IT CAN BE SAID THAT THERE IS ONE POTENTIAL ROOT CAUSE WHICH COULD BE CONNECTED WITH PACKAGING PROCESS OF SUBJECT PRODUCT. DURING SEALING PROCESS THERE COULD HAPPEN THAT PACKAGING MACHINE SLICED THE INFUSION SET. THIS BATCH HAVE BEEN PACKED AT PACKAGING MACHINE MULTIVAC IDN 373. IF CUSTOMER PROVIDE ADDITIONAL INFORMATION THAT COULD HELP TO CONDUCT MORE DETAIL INVESTIGATION, INVESTIGATION OF THIS CUSTOMER COMPLAINT WILL BE REVISED, AS NEEDED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS CAZIN, BOSNIA. THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    C61 (515302) TUBING WAS FOUND FLATTENED BEFORE USAGE. MULTIPLE C61 WAS FOUND WITH DEFECT, ATTACHED PIR TRACKER FOR YOUR REFERENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD PHASEAL¿ SECONDARY SETS C61 WERE FOUND WITH DAMAGED/FLATTENED TUBING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "C61 (515302) TUBING WAS FOUND FLATTENED BEFORE USAGE. MULTIPLE C61 WAS FOUND WITH DEFECT"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801898 BD PHASEAL¿ SECONDARY SET C61 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON 1024992 00382905153020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown