BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA 20G/45MM

    MDR report key: 19288010 · Received May 10, 2024

    Report

    Report Number
    2243072-2024-00613
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 31, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382906822451
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BASED ON THE DHR REVIEW, THERE IS AN OUTGOING INSPECTION TO INSPECT FOR PRODUCT DAMAGED DURING THE IN-PROCESS INSPECTION, NO NEEDLE BROKEN / NEEDLE BENT QN BEING RAISE FOR THE ASSEMBLY NEEDLE (AN) BATCH USED TO PRODUCE THIS COMPLAINT BATCH. NO PHOTO IS RECEIVED. 2 REPRESENTATIVE SAMPLES WERE RECEIVED. 1 SAMPLE WAS INSPECTED FOR DAMAGED CATHETER TIP, MEASUREMENT OF CATHETER TIP INTERNAL DIMETER 0.67 +/- 0.01MM, CATHETER TAPER 2.5 +/- 1.0MM, TIP WALL THICKNESS 0.085 +/- 0.015MM, BEVELED LENGTH 58 - 58.5MM & BEVEL ANGEL 15 - 30 DEGREE. THERE IS NO DAMAGED CATHETER TIP AND ALL THE ABOVE DIMENSIONS ABOVE WERE WITHIN SPECIFICATION FOR THE ABOVE MENTIONED SAMPLE. THE OTHER SAMPLE WAS INSPECTED ON THE PENETRATION FORCE. THE PENETRATION FORCE OF THE CATHETER WAS WITHIN SPECIFICATION OF 0.55N MAXIMUM. THE CUSTOMER¿S EXPERIENCE OF NEEDLE BROKEN / NEEDLE BENT CANNOT BE DETERMINE. THE COMPLAINT TREND WILL BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ARTERIAL CANNULA 20G/45MM NEEDLE BROKE. I AM WRITING TO BRING TO YOUR ATTENTION AN ISSUE WE ENCOUNTERED DURING A RECENT PROCEDURE. DR. WAS PUTTING HD CATHETER FOR PATIENT, UHID 270128241, WE OBSERVED THAT THE GUIDE WIRE WAS BENDING DURING CATHETER INSERTION, WHICH COMPROMISED THE PRECISION OF THE PROCESS. ADDITIONALLY, THE ARTERIAL CANNULA BROKE WHILE INSERTING THE LINE, RESULTING IN A DISRUPTION TO THE PROCEDURE. I KINDLY REQUEST YOUR TEAM TO INVESTIGATE THIS MATTER FURTHER AND TAKE NECESSARY ACTION TO PREVENT SUCH OCCURRENCES IN THE FUTURE. YOUR COOPERATION IN RESOLVING THIS ISSUE IS GREATLY APPRECIATED. DETAILS OF PRODUCT: HAEMOCENT HEMODIALYSIS CATHETER KIT LOT 3309022M POLYMED MEDICAL DEVICE BD ARTERIAL CANNULA 20G/1.10MM*45MM 49ML/MIN REF 682245 LOT:2111517.

    Description of Event or Problem · 0

    I AM WRITING TO BRING TO YOUR ATTENTION AN ISSUE WE ENCOUNTERED DURING A RECENT PROCEDURE. DR. WAS PUTTING HD CATHETER FOR PATIENT, UHID 270128241, WE OBSERVED THAT THE GUIDE WIRE WAS BENDING DURING CATHETER INSERTION, WHICH COMPROMISED THE PRECISION OF THE PROCESS. ADDITIONALLY, THE ARTERIAL CANNULA BROKE WHILE INSERTING THE LINE, RESULTING IN A DISRUPTION TO THE PROCEDURE. I KINDLY REQUEST YOUR TEAM TO INVESTIGATE THIS MATTER FURTHER AND TAKE NECESSARY ACTION TO PREVENT SUCH OCCURRENCES IN THE FUTURE. YOUR COOPERATION IN RESOLVING THIS ISSUE IS GREATLY APPRECIATED. DETAILS OF PRODUCT: HAEMOCENT HEMODIALYSIS CATHETER KIT LOT 3309022M POLYMED MEDICAL DEVICE BD ARTERIAL CANNULA 20G/1.10MM*45MM 49ML/MIN REF 682245 LOT:2111517.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2499689 ARTERIAL CANNULA 20G/45MM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 2111517 00382906822451

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown