BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.00IN HF Y

    MDR report key: 19385774 · Received May 23, 2024

    Report

    Report Number
    1710034-2024-00482
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    May 1, 2024
    Report Date
    June 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383536 AND LOT NUMBER 4030906 . THE REVIEW 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. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL# 383536 BATCH# 4030906 IT WAS REPORTED BY CUSTOMER THAT THE ISSUE IS WHEN THEY GO TO SEPARATE THE NEEDLE FROM THE CATHETER GRAY PIECE TO HUB IT DOES NOT WANT TO SEPARATE FROM THE CATHETER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE HAD ANOTHER ISSUE TODAY WITH THE 20G NEXIVA. LOT# 4030906 REF# (B)(4). I THINK WHEN WE SPOKE THE OTHER DAY WE MAY HAVE HAD A MISUNDERSTANDING OF THE ISSUE. THE STAFF ARE USING PROPER PROCEDURE TO ACCESS THE VEIN. ONCE THEY ACCESS THEY ADVANCE THE CATHETER UNTIL THE NEEDLE IS COMPLETELY RETRACTED. THIS OCCURS WITHOUT ISSUE. THE ISSUE IS WHEN THEY GO TO SEPARATE THE NEEDLE FROM THE CATHETER GRAY PIECE TO HUB IT DOES NOT WANT TO SEPARATE FROM THE CATHETER. THE RISK IS PULLING THE CATHETER OUT. WE HAD ANOTHER 20G NEXIVA ISSUE WITH DISCONNECTING. LOT 4030906 REF (B)(4). IT APPEARS THAT IT MAY BE ISOLATED TO THIS LOT NUMBER. HAVE YOU HEARD ANYTHING ABOUT THIS ISSUE FROM BD? I HAVE THE PACKAGING FOR THIS ONE HOWEVER THEY DISCARDED THE NEEDLE. ADDITIONAL INFORMATION: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THERE WAS NO PATIENT HARM OR INJURY. COMPLICATION OR NEGATIVE OUTCOME, REQUIRED THE USE OF HEMOSTATS TO GET THE LEVERAGE NEEDED TO SEPARATE THE NEEDLE FROM THE CATHETER THE GRAY AREA OF THE CATHETER. THE PATIENT DID NOT REQUIRE TO BE RE-ACCESSED. HAS ONLY BEEN FOUND WITH THIS LOT NUMBER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688777 NEXIVA 20GA 1.00IN HF Y CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 4030906 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown