BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8307324 · Received February 5, 2019

    Report

    Report Number
    1710034-2019-00147
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 14, 2019
    Report Date
    April 26, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBER 8263628; THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE 1 FROM 24SEP18 THROUGH 3OCT18. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED SEVEN NON-RELATED QNS WERE INITIATED ON THIS LOT THAT WOULD NOT IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. DHR REVIEW WAS PERFORMED ON LOT NUMBER 8235504; THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE 1 FROM 26AUG18 THRU 05SEPT18. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED TWO NON-RELATED QNS WERE INITIATED ON THIS LOT THAT WOULD NOT IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. RECEIVED TWO USED NEXIVA 20GA UNITS. ONE UNIT WAS IN AN OPENED PACKAGE AND ONE USED UNIT IN A PLASTIC CONTAINER AND AN OPENED EMPTY PACKAGE FROM CATALOG NUMBER 383536, LOT NUMBER 8263628. ALSO RECEIVED ONE NEXIVA 20GA EMPTY PACKAGE FROM THE CATALOG 383536, LOT NUMBER 8235504. FOUR PHOTOS WERE SUBMITTED FOR EVALUATION: ¿PHOTO ONE DISPLAYED 2 PLASTIC BAGS WITH A 20GA UNIT AND OPENED PAGES IN EACH BAG. ¿PHOTO TWO DISPLAYED TWO PLASTIC BAGS WITH THE PAPER TOP WEB (LABEL) ¿PHOTO THREE DISPLAYED A 20GA STRAIGHT ADAPTER WITH AN ATTACHED Q-SYTE UNIT AND THE NEEDLE WITH THE CATHETER TUBING INSIDE OF A SPECIMEN JAR. ¿PHOTO FOUR DISPLAYED A 20GA WINGED ADAPTER WITH THE NEEDLE/CATHETER TUBING AND A LOOSE Q-SYTE UNIT WITH AN ATTACHED BLUE CAP. VISUAL/MICROSCOPIC EVALUATION: BAG 1 ¿ NEEDLE HAD SPEARED THRU THE CATHETER TUBING WALL APPROXIMATELY ½ INCH BELOW THE CATHETER TIP. THERE WERE BODILY FLUIDS/MEDS WAS PRESENT IN THE CATHETER TUBING, NOTCH AND BEVEL OF THE NEEDLE. BAG 2 ¿ NEEDLE HAD SPEARED THRU THE CATHETER TUBING AT THE NOSE OF THE WINGED ADAPTER BAG 3 ¿ NO OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. BASED ON THE EVALUATION OF THE SUBMITTED PHOTOS THE DEFECT CATHETER BROKE/SEPARATED AFTER PLACEMENT WAS NOT CONFIRMED. THE PHOTOS DID NOT DISPLAY ANY VISIBLE INDICATION THE CATHETER WAS BROKE OR HAD BEEN SEPARATED. CONCLUSION: INDETERMINATE: THE DEFECT CATHETER BROKE/CATHETER AFTER PLACEMENT WAS IDENTIFIED AND CONFIRMED WITH THE RETURNED UNITS. BODILY FLUIDS/MEDS OBSERVED WITHIN THE UNIT INDICATES THE NEEDLE AND CATHETER WERE CORRECTLY ASSEMBLED AT THE TIME OF USE. THE DEFECT ASSOCIATED WITH THIS INCIDENT REPORT WAS CAUSED BY THE CANNULA SPEARING THE CATHETER TUBING WALL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS HAD HUB SEPARATION DURING INSERTION. THIS OCCURRED ON 2 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    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 BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS HAD HUB SEPARATION DURING INSERTION. THIS OCCURRED ON 2 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98753 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8263628 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other