BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9489583 · Received December 18, 2019

    Report

    Report Number
    1710034-2019-01338
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    August 16, 2019
    Report Date
    January 27, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES FOR EVALUATION. BD RECEIVED A TOTAL OF SEVEN 20GA NEXIVA UNITS; 3 SEALED UNITS FROM LOT NUMBER 9092781, 4 UNITS: 3 SEALED AND 1 OPEN FROM LOT NUMBER 9149613. NO UNITS WERE RECEIVED FROM LOT NUMBER 9105605. ALL COMPONENTS WERE INTACT. THROUGH THE VISUAL EXAMINATION THERE WAS NO PHYSICAL MECHANICAL DAMAGE OBSERVED ON ANY OF THE COMPONENTS OF THE UNITS RECEIVED. THE LIE DISTANCE ON ALL UNITS RECEIVED WAS FOUND ACCEPTABLE PER SPECIFICATIONS. A FLASHBACK TEST WAS PERFORMED WHERE ALL UNITS WERE INTRODUCED INTO AN ARTIFICIAL VEIN. LIQUID WAS RAPIDLY SEEN THROUGH THE NOTCH/CATHETER TUBING. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN THE REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS HAD BLOCKAGE IN THEIR TUBING DURING USE, AND BLOOD RETURN COULD NOT BE OBSERVED. A TUBE REPORTEDLY "EXPLODED" AS A RESULT AND SPILLED BLOOD. LOT #'S 9105605 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. ADDITIONALLY, LOT# 9092781 WAS REPORTED TO HAVE HAD 13 OCCURRENCES OF THIS EVENT, WHILE LOT# 9149631 HAD 224 OCCURRENCES. HOWEVER, THE DATES AND/OR PATIENT INFORMATION FOR THESE OCCURRENCES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM THESE DEPTS ARE EXPERIENCING IS A BLOCKAGE IN THE CATH TUBE. ONCE THEY ACCESS THE VESSEL, THE NURSES CANNOT OBSERVE IMMEDIATE BLOOD RETURN ALONG THE CATHETER TUBING." "AN ADVERSE EVENT OF THE TUBE EXPLODING OF BLOOD."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9105605. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2019-04-15. MEDICAL DEVICE LOT #: 9092781. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2019-04-02. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 9149631. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2019-05-29. 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 BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS HAD BLOCKAGE IN THEIR TUBING DURING USE, AND BLOOD RETURN COULD NOT BE OBSERVED. A TUBE REPORTEDLY "EXPLODED" AS A RESULT AND SPILLED BLOOD. LOT #'S 9105605 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. ADDITIONALLY, LOT# 9092781 WAS REPORTED TO HAVE HAD 13 OCCURRENCES OF THIS EVENT, WHILE LOT# 9149631 HAD 224 OCCURRENCES. HOWEVER, THE DATES AND/OR PATIENT INFORMATION FOR THESE OCCURRENCES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PROBLEM THESE DEPTS ARE EXPERIENCING IS A BLOCKAGE IN THE CATH TUBE. ONCE THEY ACCESS THE VESSEL, THE NURSES CANNOT OBSERVE IMMEDIATE BLOOD RETURN ALONG THE CATHETER TUBING." "AN ADVERSE EVENT OF THE TUBE EXPLODING OF BLOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286681 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383536 SEE SECTION H.10. 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other