BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8565121 · Received April 30, 2019

    Report

    Report Number
    1710034-2019-00468
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 9, 2019
    Report Date
    June 19, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835127
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADDITIONAL INFORMATION IS AS FOLLOWS: DATE OF EVENT: (B)(6) 2019.

    Additional Manufacturer Narrative · 0

    G.5. PMA / 510(K)#: K183399.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLE, BATCH, OR LOT CODE WAS PROVIDED. THIS COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED & TRENDED FOR FUTURE OCCURRENCES. THE COMPLAINT WAS DEEMED AS MDR REPORTABLE THEREFORE A SUBMISSION WILL BE PERFORMED. SHALL A SAMPLE OR LOT NUMBER BECOME AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND AN INVESTIGATION WILL TAKE PLACE. THIS COMPLAINT WILL BE CLOSED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO.: 383512. BATCH NO.: UNKNOWN. IT WAS REPORTED THAT SALINE SQUIRTED OUT OF THE SIDE OF THE TUBING AT THE PORT JUNCTION AND THAT TUBING WAS SPLIT OPEN. PER PIR 3012484: DIRECT FROM EMAIL: NO LOT # IDENTIFIED. THIS #22 NEXIVA IV WAS DWELLING FOR ABOUT 7 DAYS, WAS NOT UTILIZED FOR ANY MEDICATIONS. WAS ONLY FOR FLUSH Q SHIFT WITH 0.9NS. (OUR MDS LIKE OUR PATIENTS TO HAVE PIVS FOR MOST OF THE DURATION OF STAY, EVEN WHEN NOT INDICATED. I KNOW¿) WITH ROUTINE FLUSH AND DRESSING CHANGE ON DAY 7, I WENT TO FLUSH, AND SALINE SQUIRTED OUT OF THE SIDE OF THE TUBING AT THE PORT JUNCTION. FLUSHED WITH 10CC SYRINGE. CLAMP WAS PLACED LOWER ON TUBING AND WAS OPEN. THIS WAS A #22 NEXIVA CATHETER. SITE WAS ASYMPTOMATIC. CATHETER WAS REMOVED AND INSPECTED, WITH TUBING SPLIT NEARLY IN HALF. THIS PATIENT ALSO EXPERIENCED THIS SAME SITUATION WITH A #24 PIV, ALSO HAD ABOUT 1 WEEK DWELL, HAD SALINE SQUIRT OUT AT SAME JUNCTION, BUT WAS ABOUT A PINHOLE SIZE. I DID REMOVE THAT IV, DIDN¿T REPORT IT AS I THOUGHT IT WAS AN ISOLATED INCIDENT, AND A TIME ISSUE. I HAVE NEVER EXPERIENCED THIS ISSUE ON ANY OTHER PATIENT, OR HAVE HAD ANY REPORTS FROM ANY OF OUR STAFF OF THIS ISSUE. DEFINITELY CONCERNED IT COULD BE PATIENT MANIPULATION. OF COURSE CAN¿T PROVE THAT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO.: 383512, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT SALINE SQUIRTED OUT OF THE SIDE OF THE TUBING AT THE PORT JUNCTION AND THAT TUBING WAS SPLIT OPEN. PER PIR (B)(4): DIRECT FROM EMAIL: NO LOT # IDENTIFIED. THIS #22 NEXIVA IV WAS DWELLING FOR ABOUT 7 DAYS, WAS NOT UTILIZED FOR ANY MEDICATIONS. WAS ONLY FOR FLUSH Q SHIFT WITH 0.9NS. (OUR MDS LIKE OUR PATIENTS TO HAVE PIVS FOR MOST OF THE DURATION OF STAY, EVEN WHEN NOT INDICATED. I KNOW¿) WITH ROUTINE FLUSH AND DRESSING CHANGE ON DAY 7, I WENT TO FLUSH, AND SALINE SQUIRTED OUT OF THE SIDE OF THE TUBING AT THE PORT JUNCTION. FLUSHED WITH 10CC SYRINGE. CLAMP WAS PLACED LOWER ON TUBING AND WAS OPEN. THIS WAS A #22 NEXIVA CATHETER. SITE WAS ASYMPTOMATIC. CATHETER WAS REMOVED AND INSPECTED, WITH TUBING SPLIT NEARLY IN HALF. THIS PATIENT ALSO EXPERIENCED THIS SAME SITUATION WITH A #24 PIV, ALSO HAD ABOUT 1 WEEK DWELL, HAD SALINE SQUIRT OUT AT SAME JUNCTION, BUT WAS ABOUT A PINHOLE SIZE. I DID REMOVE THAT IV, DIDN¿T REPORT IT AS I THOUGHT IT WAS AN ISOLATED INCIDENT, AND A TIME ISSUE. I HAVE NEVER EXPERIENCED THIS ISSUE ON ANY OTHER PATIENT, OR HAVE HAD ANY REPORTS FROM ANY OF OUR STAFF OF THIS ISSUE. DEFINITELY CONCERNED IT COULD BE PATIENT MANIPULATION. OF COURSE CAN¿T PROVE THAT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO.: 383512 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT SALINE SQUIRTED OUT OF THE SIDE OF THE TUBING AT THE PORT JUNCTION AND THAT TUBING WAS SPLIT OPEN. PER PIR 3012484: DIRECT FROM EMAIL: NO LOT # IDENTIFIED. THIS #22 NEXIVA IV WAS DWELLING FOR ABOUT 7 DAYS, WAS NOT UTILIZED FOR ANY MEDICATIONS. WAS ONLY FOR FLUSH Q SHIFT WITH 0.9NS. (OUR MDS LIKE OUR PATIENTS TO HAVE PIVS FOR MOST OF THE DURATION OF STAY, EVEN WHEN NOT INDICATED. I KNOW¿) WITH ROUTINE FLUSH AND DRESSING CHANGE ON DAY 7, I WENT TO FLUSH, AND SALINE SQUIRTED OUT OF THE SIDE OF THE TUBING AT THE PORT JUNCTION. FLUSHED WITH 10CC SYRINGE. CLAMP WAS PLACED LOWER ON TUBING AND WAS OPEN. THIS WAS A #22 NEXIVA CATHETER. SITE WAS ASYMPTOMATIC. CATHETER WAS REMOVED AND INSPECTED, WITH TUBING SPLIT NEARLY IN HALF. THIS PATIENT ALSO EXPERIENCED THIS SAME SITUATION WITH A #24 PIV, ALSO HAD ABOUT 1 WEEK DWELL, HAD SALINE SQUIRT OUT AT SAME JUNCTION, BUT WAS ABOUT A PINHOLE SIZE. I DID REMOVE THAT IV, DIDN¿T REPORT IT AS I THOUGHT IT WAS AN ISOLATED INCIDENT, AND A TIME ISSUE. I HAVE NEVER EXPERIENCED THIS ISSUE ON ANY OTHER PATIENT, OR HAVE HAD ANY REPORTS FROM ANY OF OUR STAFF OF THIS ISSUE. DEFINITELY CONCERNED IT COULD BE PATIENT MANIPULATION. OF COURSE CAN¿T PROVE THAT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 LEAKAGE OCCURRED WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "MATERIAL NO.: 383512, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT SALINE SQUIRTED OUT OF THE SIDE OF THE TUBING AT THE PORT JUNCTION AND THAT TUBING WAS SPLIT OPEN. PER PIR (B)(4): DIRECT FROM EMAIL: NO LOT # IDENTIFIED. THIS #22 NEXIVA IV WAS DWELLING FOR ABOUT 7 DAYS, WAS NOT UTILIZED FOR ANY MEDICATIONS. WAS ONLY FOR FLUSH Q SHIFT WITH 0.9NS. (OUR MDS LIKE OUR PATIENTS TO HAVE PIVS FOR MOST OF THE DURATION OF STAY, EVEN WHEN NOT INDICATED. I KNOW¿) WITH ROUTINE FLUSH AND DRESSING CHANGE ON DAY 7, I WENT TO FLUSH, AND SALINE SQUIRTED OUT OF THE SIDE OF THE TUBING AT THE PORT JUNCTION. FLUSHED WITH 10CC SYRINGE. CLAMP WAS PLACED LOWER ON TUBING AND WAS OPEN. THIS WAS A #22 NEXIVA CATHETER. SITE WAS ASYMPTOMATIC. CATHETER WAS REMOVED AND INSPECTED, WITH TUBING SPLIT NEARLY IN HALF. THIS PATIENT ALSO EXPERIENCED THIS SAME SITUATION WITH A #24 PIV, ALSO HAD ABOUT 1 WEEK DWELL, HAD SALINE SQUIRT OUT AT SAME JUNCTION, BUT WAS ABOUT A PINHOLE SIZE. I DID REMOVE THAT IV, DIDN'T REPORT IT AS I THOUGHT IT WAS AN ISOLATED INCIDENT, AND A TIME ISSUE. I HAVE NEVER EXPERIENCED THIS ISSUE ON ANY OTHER PATIENT, OR HAVE HAD ANY REPORTS FROM ANY OF OUR STAFF OF THIS ISSUE. DEFINITELY CONCERNED IT COULD BE PATIENT MANIPULATION. OF COURSE CAN'T PROVE THAT.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358642 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 30382903835127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other