BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ NEXIVA 20GA 1.00IN HF Y

    MDR report key: 8152704 · Received December 11, 2018

    Report

    Report Number
    1710034-2018-00888
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 21, 2018
    Report Date
    January 24, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K102520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED ONE 20GA NEXIVA CATHETER-ADAPTER EXTENSION SET ALONG WITH A PIECE OF TOP WEB FROM LOT NUMBER: 8208729. THE NEEDLE ASSEMBLY WAS NOT RETURNED FOR EVALUATION. DHR REVIEW REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED A QUALITY NOTIFICATION (EXTENSION TUBING BOND STRENGTH OOS) WAS INITIATED DURING THE BUILD OF THIS LOT THAT COULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. QN¿S (FOREIGN), (FOREIGN), (DIFFICULT RETRACTION), (INCOMPLETE SEAL) AND (SUSPECT SPLICE TAPE TOP WEB) WERE ALSO INITIATED DURING THE BUILD OF THIS LOT NUMBER. INVESTIGATION CONCLUSION: NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON THE UNIT RECEIVED FOR EVALUATION. NO TESTING OR OBSERVATIONS RELATED TO THE NEEDLE CONDITION COULD BE PERFORMED, SINCE THE NEEDLE ASSEMBLY WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE DESCRIPTION: THE DEFECT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT IDENTIFIED OR CONFIRMED; AS THE NEEDLE ASSEMBLY WERE NOT PROVIDED FOR THIS INCIDENT, THEREFORE, A DEFINITE ROOT CAUSE COULD NOT BE ESTABLISHED. RATIONALE: A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED MONTHLY. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ NEXIVA 20GA 1.00IN HF Y HAD RETRACTION FAILURE RESULTING IN NEEDLE STICK INJURY.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ NEXIVA 20GA 1.00IN HF Y HAD RETRACTION FAILURE RESULTING IN NEEDLE STICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989368 BD¿ NEXIVA 20GA 1.00IN HF Y PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8208729 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other