BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 18 GA X 1-1/4 IN SINGLE PORT

    MDR report key: 10738233 · Received October 26, 2020

    Report

    Report Number
    1710034-2020-00677
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 30, 2020
    Report Date
    December 29, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 0107575. D4: MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. H4: DEVICE MANUFACTURE DATE: 2020-04-16. D4: MEDICAL DEVICE LOT #: 0048567. D4: MEDICAL DEVICE EXPIRATION DATE: 2023-01-31. H4: DEVICE MANUFACTURE DATE: 2020-02-17. D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2020-11-13. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE RETURNED REPRESENTATIVE SAMPLES AND PHOTOGRAPHS PROVIDED BY THE FACILITY. BD RECEIVED SIXTEEN UNUSED REPRESENTATIVE 18GA NEXIVA CLOSED IV CATHETER UNITS WITHIN UNDAMAGED SEALED PACKAGES. THE UNITS ARE FROM ITEM NUMBER 383519. TWELVE UNITS ARE FROM LOT NUMBER 0107575 AND FOUR UNITS ARE FROM LOT NUMBER 0048567. ALL COMPONENTS ARE PRESENT AND INTACT. IN ADDITION, TWO PHOTOGRAPHS WERE SUBMITTED WHICH DISPLAYED THE 18GA BD NEXIVA WINGED ADAPTER WITH EXTENSION SET THAT IS PLACED AT AN INJECTION SITE ON A WRIST. THERE IS MEDIA PRESENT AT THE CANISTER. THE UNIT DISPLAYS A DROPLET OF A CLEAR FLUID AT THE END OF THE CANISTER. THROUGH THE VISUAL OBSERVATION OF THE REPRESENTATIVE UNITS, THERE WAS NO PHYSICAL-MECHANICAL DAMAGE TO ANY OF THE UNITS-COMPONENTS. A FLASHBACK TEST WAS PERFORMED USING THE LABORATORY SUPPLIED ARTIFICIAL VEIN AND RED WATER/DYE MIX TO PERFORM THE TEST. THERE WERE NO OBSTRUCTIONS INHIBITING THE FLASHBACK. THE NEEDLES WERE THEN PULLED BACK AND DECOUPLED FROM THE CATHETER AND EXTENSION TUBING ASSEMBLIES; AT THIS TIME VISUAL OBSERVATION OF THE AREA OF THE CANISTER AND SECONDARY SEPTUM WAS CONDUCTED. A WATER/AIR LEAK TEST WAS ALSO PERFORMED. LEAKAGE WAS NOT OBSERVED WITH EITHER TEST. THE RETURNED REPRESENTATIVE UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THE PHOTOGRAPH SUBMITTED CONFIRMED THAT LEAKAGE OCCURRED. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED BY OBSERVATION OF THE PHOTOGRAPH, A ROOT CAUSE COULD NOT BE DETERMINED. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 18 GA X 1-1/4 IN SINGLE PORT LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS PREPARED FOR SECTIO, PATIENT HAD PERIPHERAL VENOUS CATHETER NEXIVA 18 G AT THE LINK FOREARM. ACCORDING TO THE STANDARD, A SECOND NEXIVA CATHETER 18 G WAS PLACED AT THE RIGHT FOREARM, THE VESSELS OF THE PATIENT WERE IN A GOOD STATUS. AFTER A SHORT TIME (BEFORE CUTTING), THE ANESTHETIST NOTICED, THAT THE PLASTER WAS WET AND THE UNDERLAY WAS HUMID. THE PLASTER WAS REMOVED TO BE ABLE TO CONTROL THE INSERTION POINT, THE INSERTION POINT WAS BLAND, THE INFUSION SOLUTION EMPTIED THROUGH THE CONUS. THE ACCESS DEVICE COULD NOT BE USED ANYMORE GIVEN HALF THE SOLUTION LEAKED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEXIVA 18 GA X 1-1/4 IN SINGLE PORT LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS PREPARED FOR SECTION, PATIENT HAD PERIPHERAL VENOUS CATHETER NEXIVA 18 G AT THE LINK FOREARM. ACCORDING TO THE STANDARD, A SECOND NEXIVA CATHETER 18 G WAS PLACED AT THE RIGHT FOREARM, THE VESSELS OF THE PATIENT WERE IN A GOOD STATUS. AFTER A SHORT TIME (BEFORE CUTTING), THE ANESTHETIST NOTICED, THAT THE PLASTER WAS WET AND THE UNDERLAY WAS HUMID. THE PLASTER WAS REMOVED TO BE ABLE TO CONTROL THE INSERTION POINT, THE INSERTION POINT WAS BLAND, THE INFUSION SOLUTION EMPTIED THROUGH THE CONUS. THE ACCESS DEVICE COULD NOT BE USED ANYMORE GIVEN HALF THE SOLUTION LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203117 NEXIVA 18 GA X 1-1/4 IN SINGLE PORT INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383519 SEE H.10 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1