BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8333124 · Received February 12, 2019

    Report

    Report Number
    1710034-2019-00172
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Date of Event
    January 14, 2019
    Report Date
    April 24, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835172
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THERE WERE 3 POTENTIAL LOTS REPORTED BUT THE EXACT LOT COULD NOT BE DETERMINED. INFORMATION FOR THE POTENTIAL LOTS IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 8214840, D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2021, H.4. DEVICE MANUFACTURE DATE: 8/2/2018; D.4. MEDICAL DEVICE LOT #: 8200535, D.4. MEDICAL DEVICE EXPIRATION DATE: 6/30/2021, H.4. DEVICE MANUFACTURE DATE: 7/19/2018; D.4. MEDICAL DEVICE LOT #: 8152774, D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2021, H.4. DEVICE MANUFACTURE DATE: 6/1/2018. H.6. INVESTIGATION SUMMARY: DHR: ALL CHALLENGE, SET UP AND IN PROCESS SAMPLES WERE PERFORMED PER SPECIFICATIONS. NO QNS WERE INITIATED DURING PRODUCTION. RECEIVED ONE 20GA BD NEXIVA CONSISTING OF CATHETER-ADAPTER EXTENSION SET AND A NEEDLE-SHIELD ASSEMBLY WITH A MISCELLANEOUS NEEDLE COVER. THE PACKAGING WAS NOT RETURNED. VISUAL/MICROSCOPIC EVALUATION: THE NEEDLE-SAFETY SHIELD ASSEMBLY WAS MISSING THE V-CLIP, THEREFORE PREVENTING THE CANNULA FROM SUCCESSFULLY LOCKING INTO THE SHIELD. CONCLUSION: MANUFACTURING: ALTHOUGH A DEFINITE SOURCE THAT CAUSED THE V - CLIP TO BE MISSED FROM THE ASSEMBLY IS UNKNOWN, THE DEFECT IS MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY SYSTEM ON A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM DID NOT ACTIVATE AND LEFT THE NEEDLE EXPOSED.

    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 THE SAFETY SYSTEM ON A BD NEXIVA CLOSED IV CATHETER SYSTEM DID NOT ACTIVATE AND LEFT THE NEEDLE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123168 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 30382903835172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other