BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET SN404 W/O BP Y-CONN

    MDR report key: 10946637 · Received December 4, 2020

    Report

    Report Number
    2243072-2020-01998
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 9, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED TO SBDM, SBDM INVESTIGATED IT TO FIND OUT THE ROOT CAUSE OF THE CASE BY RETENTION SAMPLES. SBDM INSPECTED THE RETENTION SAMPLES FOR THE COMPLAINT CASE DUE TO NOT RECEIVING THE COMPLAINT SAMPLES, FOUND THAT THERE WAS NO BLOCKAGE. THE LIKELY CAUSE IS TEMPORARY EXTERNAL FACTOR COULD BE THE ROOT CAUSE OF THE COMPLAINT CASE. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD OF EXPECTED LOT NUMBER OF THE COMPLAINT CASE (LOT NO. 2010061, 2010271 & 2011042), THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE WAS NO SAME ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IV SET SN404 W/O BP Y-CONN HAD FLOW ISSUES ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLUID WAS NOT DRIPPED INTO IV SET CHAMBER. THE FLUID WAS NOT DRIPPED INTO IV SET (SN404) CHAMBER. PLEASE CHECK THE SAMPLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). 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 IV SET SN404 W/O BP Y-CONN HAD FLOW ISSUES ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLUID WAS NOT DRIPPED INTO IV SET CHAMBER. THE FLUID WAS NOT DRIPPED INTO IV SET (SN404) CHAMBER. PLEASE CHECK THE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415153 IV SET SN404 W/O BP Y-CONN INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1