BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA DIFFUSICS 22G X 1.00 IN

    MDR report key: 11817046 · Received May 13, 2021

    Report

    Report Number
    1710034-2021-00394
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 13, 2021
    Report Date
    July 13, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835912
    PMA / PMN Number
    K123734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/19/2021 D.4. MEDICAL DEVICE LOT #: 0233531 D.4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2023 H.4. DEVICE MANUFACTURE DATE: 9/14/2020 D.4. MEDICAL DEVICE LOT #: 0241007 D.4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2023 H.4. DEVICE MANUFACTURE DATE: 9/29/2020 D.4. MEDICAL DEVICE LOT #: 0300443 D.4. MEDICAL DEVICE EXPIRATION DATE: 10/31/2023 H.4. DEVICE MANUFACTURE DATE: 11/5/2020 H.6. INVESTIGATION: SAMPLES WERE RETURNED TO THE DECONTAMINATION PLANT OF MATERIAL 383591. NO DEFECTS OR DAMAGED WERE FOUND ON THE SAMPLES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBERS. THE REVIEWS DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT COULD NOT BE FOUND AND THE FAILURE WAS NOT REPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEXIVA DIFFUSICS 22G X 1.00 IN BROKE AT THE CATHETER OR HAD FOREIGN MATTER. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SAMPLES HAVE BEEN RECEIVED FOR THE FOLLOWING LOT'S VERBATIM: NOTIFICATION SUMMARY (SEE PR DETAILS BELOW): HELLO, WE RECEIVED SAMPLES FOR THIS PR UNDER FEDEX TRACKING NUMBER (B)(6) . HOWEVER THE FOLLOWING THREE LOT NUMBERS WERE ALSO RETURNED THAT ARE NOT RECORDED IN THE PARENT RECORD. - LOT NUMBER 0233531, MATERIAL NUMBER 383591 (2 DEVICES) NEXIVA DIFFUSICS IN A SEALED PACKAGE - LOT NUMBER 0241007, MATERIAL NUMBER 383591 (1 DEVICES) NEXIVA DIFFUSICS IN A SEALED PACKAGE - LOT NUMBER 0300443, MATERIAL NUMBER 383591 (1. DEVICES) NEXIVA DIFFUSICS IN A SEALED PACKAGE"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEXIVA DIFFUSICS 22G X 1.00 IN BROKE AT THE CATHETER OR HAD FOREIGN MATTER. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SAMPLES HAVE BEEN RECEIVED FOR THE FOLLOWING LOT'S. VERBATIM: NOTIFICATION SUMMARY (SEE PR DETAILS BELOW): HELLO, WE RECEIVED SAMPLES FOR THIS PR UNDER (B)(6) TRACKING NUMBER (B)(4). HOWEVER THE FOLLOWING THREE LOT NUMBERS WERE ALSO RETURNED THAT ARE NOT RECORDED IN THE PARENT RECORD. LOT NUMBER 0233531, MATERIAL NUMBER 383591 (2 DEVICES) NEXIVA DIFFUSICS IN A SEALED PACKAGE. LOT NUMBER 0241007, MATERIAL NUMBER 383591 (1 DEVICES) NEXIVA DIFFUSICS IN A SEALED PACKAGE. LOT NUMBER 0300443, MATERIAL NUMBER 383591 (1. DEVICES) NEXIVA DIFFUSICS IN A SEALED PACKAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718695 NEXIVA DIFFUSICS 22G X 1.00 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383591 SEE H.10 30382903835912

    Patients

    Seq Age Sex Outcome Treatment
    1