BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT 22GA 1.00IN (0.9 MM X 25 MM)

    MDR report key: 8931414 · Received August 26, 2019

    Report

    Report Number
    1710034-2019-00927
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 1, 2019
    Report Date
    September 5, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835127
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THERE WERE NO SAMPLES OR PHOTOS AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS EVENT BUT WITHOUT A SAMPLE NO CORRECTIVE ACTIONS COULD BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD NEXIVA SINGLE PORT 22GA 1.00IN (0.9 MM X 25 MM) HAS BEEN FOUND EXPERIENCING HEMOLYSIS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE STAFF WAS UNABLE TO DRAW BLOOD / OR DREW VERY SLOW WHICH LEAD TO HEMOLYZED SPECIMEN. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: 8/1/2019 AT 0815: 22 GAUGE X 1 INCH BD NEXIVA IV CATHETER WITH LOT NUMBER 9137627 NOT WORKING PROPERLY. CATHETER WAS IN THE VEIN AND WOULD NOT DRAW BLOOD/ OR DREW VERY SLOW TO HEMOLYZE SPECIMEN. BLUE NEEDLESS TRANSFER DEVICE NOR SYRINGE DID NOT WORK TO DRAW BLOOD/ OR DREW VERY SLOW TO LEAD TO HEMOLYSIS AND PATIENT BEING STUCK ADDITIONAL TIMES FOR BLOOD. IV CATHETER FLUSHED WITHOUT PROBLEMS. CATHETER WAS DISCARDED AFTER BEING REMOVED FROM PATIENT, BUT ADDITIONAL PRODUCT INFORMATION PROVIDED BELOW. THIS EVENT REQUIRED PATIENT TO BE STUCK AN ADDITIONAL TIME FOR IV PLACEMENT AND BLOOD DRAW. IV CATHETER INFORMATION: EXPIRATION DATE: 2022-04-30, ITEM: 22 GA 1.00 IN BD NEXIVA CATHETER, LOT #: 9137627 AND REFERENCE #: 383512.

    Additional Manufacturer Narrative · 1

    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 HAS BEEN REPORTED THAT ONE BD NEXIVA SINGLE PORT 22GA 1.00IN (0.9 MM X 25 MM) HAS BEEN FOUND EXPERIENCING HEMOLYSIS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE STAFF WAS UNABLE TO DRAW BLOOD / OR DREW VERY SLOW WHICH LEAD TO HEMOLYZED SPECIMEN. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: ON (B)(6) 2019 AT 0815: 22 GAUGE X 1 INCH BD NEXIVA IV CATHETER WITH LOT NUMBER 9137627 NOT WORKING PROPERLY. CATHETER WAS IN THE VEIN AND WOULD NOT DRAW BLOOD/ OR DREW VERY SLOW TO HEMOLYZE SPECIMEN. BLUE NEEDLESS TRANSFER DEVICE NOR SYRINGE DID NOT WORK TO DRAW BLOOD/ OR DREW VERY SLOW TO LEAD TO HEMOLYSIS AND PATIENT BEING STUCK ADDITIONAL TIMES FOR BLOOD. IV CATHETER FLUSHED WITHOUT PROBLEMS. CATHETER WAS DISCARDED AFTER BEING REMOVED FROM PATIENT, BUT ADDITIONAL PRODUCT INFORMATION PROVIDED BELOW. THIS EVENT REQUIRED PATIENT TO BE STUCK AN ADDITIONAL TIME FOR IV PLACEMENT AND BLOOD DRAW. IV CATHETER INFORMATION: EXPIRATION DATE: 2022-04-30, ITEM: 22 GA 1.00 IN BD NEXIVA CATHETER, LOT #: 9137627, REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727170 BD NEXIVA SINGLE PORT 22GA 1.00IN (0.9 MM X 25 MM) INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9137627 30382903835127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other