BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ 24GA 0.75IN Y

    MDR report key: 8096850 · Received November 21, 2018

    Report

    Report Number
    1710034-2018-00852
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    October 22, 2018
    Report Date
    January 9, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835318
    PMA / PMN Number
    K102520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 8123701; MEDICAL DEVICE EXPIRATION DATE: 6/30/2021; DEVICE MANUFACTURE DATE: 7/17/2018. INVESTIGATION SUMMARY: DHR REVIEWS WERE PERFORMED ON LOT NUMBERS; 8198701 THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE 2 FROM 19JUL2018 THRU 25JUL2018. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED ONE QN 200761506 (EXTENSION KINK/TUBING) 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. TWO NON-RELATED QN (B)(4) (PARAMETER INVALID SETTINGS) AND (B)(4) (BAD SEAL). 8123701 THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE 2 FROM 8MAY2018 THROUGH 12MAY2018. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. RECEIVED 62 UNUSED NEXIVA 24 UNITS IN SEALED PACKAGES FROM CATALOG NUMBER 383531, LOT NUMBER 8198701. ALSO RECEIVED ONE UNUSED NEXIVA 24 UNIT IN A SEALED PACKAGE FROM CATALOG NUMBER 383531, LOT NUMBER 8123701. VISUAL/MICROSCOPIC EVALUATION: THE WEDGE, PRIMARY SEPTUM AND THE GREY CANISTER WERE INSTALLED PROPERLY. THERE WERE NO HOLES, KINKS, SPLITS, OR WRINKLES OBSERVED IN ANY OF THE CATHETER TUBING OR THE EXTENSION TUBING. THE EXTENSION TUBING WAS ADHERING TO THE PORT WALLS OF THE WING ADAPTER AND Y ADAPTERS. PERFORMED A WATER/AIR LEAK TEST: NO LEAKAGE OBSERVED IN ANY AREAS OF THE NEXIVA UNITS. CONCLUSION: INDETERMINATE ¿ THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED, PER THE PIR. THE DEFECT DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED REPRESENTATIVE UNITS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD NEXIVA¿ 24GA 0.75IN Y WAS LEAKED DURING USE.

    Additional Manufacturer Narrative · 1

    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 A BD NEXIVA¿ 24GA 0.75IN Y WAS LEAKED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937599 BD NEXIVA¿ 24GA 0.75IN Y PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8123701 30382903835318

    Patients

    Seq Age Sex Outcome Treatment
    1 Other