BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.00IN HF Y

    MDR report key: 11492041 · Received March 16, 2021

    Report

    Report Number
    1710034-2021-00192
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 14, 2021
    Report Date
    April 30, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/2/2021. H.6. INVESTIGATION: BD RECEIVED ONE FULLY RETRACTED 20 GAUGE NEXIVA DEVICE FROM LOT 0241582 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT TIP SHIELD DID NOT DECOUPLE FROM THE WINGED ADAPTER. UPON FURTHER INSPECTION, IT WAS FOUND THAT THE PLASTIC FROM THE TIP SHIELD WAS CATCHING ON THE V-CLIP PREVENTING RELEASE FROM THE WINGED ADAPTER. NEXT, THE TIP SHIELD AND WINGED ADAPTER WERE SEPARATED AND DAMAGE WAS SEEN ON THE INSIDE OF THE TIP SHIELD WHERE THE WINGED ADAPTER RESIDED. THIS DAMAGE WAS DETERMINED TO BE THE CAUSE OF THE RETRACTION FAILURE. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT THAT OCCURRED WHEN THE CANNULA WAS INSERTED INTO THE GRIP AND TIP SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEXIVA 20GA 1.00IN HF Y HAD DIFFICULT NEEDLE DISENGAGEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED NEEDLE RETRACTION FAILURE. PER CUSTOMER'S RESPONSE ON (B)(6) 2021. WHAT IS THE DATE OF INCIDENT? (B)(6) 2021. WAS ANYONE HURT? NO. PLEASE FIND ATTACHED A PRE-PAID FEDEX RETURN LABEL TO RETURN SAMPLES FOR EVALUATION CAN YOU PLEASE MAIL ME A CONTAINER TO MAIL IT TO YOU IN ? IT IS A NEEDLE AND I DO NOT HAVE A CONTAINER THAT IS SAFE TO PLACE IN THE MAIL - THANKS. CUSTOMER CALLED TODAY TO REPORT AN INCIDENT WITH THIS MATERIAL. THEY STATE THAT AN ER NURSE INSERTED THE NEEDLE INTO THE PATIENT, THE NEEDLE WOULD NOT PULL BACK AND SEPARATE AND THAT THE PRODUCT THEN HAD TO BE REMOVED AND THE PATIENT HAD TO BE STUCK AGAIN WITH ANOTHER NEEDLE. MATERIAL: 383536; LOT # 0241582. CUSTOMER DOES HAVE THE DEVICE AND CAN RETURN IT FOR EVALUATION. THANK YOU.".

    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 WAS REPORTED THAT A NEXIVA 20GA 1.00IN HF Y HAD DIFFICULT NEEDLE DISENGAGEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED NEEDLE RETRACTION FAILURE. VERBATIM: PER CUSTOMER'S RESPONSE (B)(6) 2021. WHAT IS THE DATE OF INCIDENT? -(B)(6) 2021. WAS ANYONE HURT? - NO . PLEASE FIND ATTACHED A PRE-PAID (B)(6) RETURN LABEL TO RETURN SAMPLES FOR EVALUATION CAN YOU PLEASE MAIL ME A CONTAINER TO MAIL IT TO YOU IN ? IT IS A NEEDLE AND I DO NOT HAVE A CONTAINER THAT IS SAFE TO PLACE IN THE MAIL - THANKS. (CUSTOMER) CALLED TODAY TO REPORT AN INCIDENT WITH THIS MATERIAL. THEY STATE THAT AN ER NURSE INSERTED THE NEEDLE INTO THE PATIENT, THE NEEDLE WOULD NOT PULL BACK AND SEPARATE AND THAT THE PRODUCT THEN HAD TO BE REMOVED AND THE PATIENT HAD TO BE STUCK AGAIN WITH ANOTHER NEEDLE. MATERIAL: 383536, LOT # 0241582. CUSTOMER DOES HAVE THE DEVICE AND CAN RETURN IT FOR EVALUATION. THANK YOU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388177 NEXIVA 20GA 1.00IN HF Y INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383536 0241582 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1