MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number	383518
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 3 of the bd nexiva¿ closed iv catheter system needls have gon through the catheter.Report 3 of 3.The following was received by the initial reporter: over the past week there have been 3 instances where the needles for our 1.75 inch peripheral ivs have cut through the catheters while inserting ultrasound guided ivs.The plastic catheter tip broke off and got lodged in the patients tissue.Additional information received on (b)(6) 2023.The product lot # was 2300204 and ref # (b)(4) for the product that we kept the sample of.That is the correct batch number.The plastic catheter tip broke off and got lodged in the patients tissue.All instances of these catheters breaking have happened while performing ultrasound guided ivs.Additional information received on (b)(6) 2023: 1.What was the patient outcome? - remains on inpatient ward.2.Was the catheter tip able to be removed? if so, how was it retrieved? - the tip has not been removed yet.3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? - an x-ray was done and the cannula was noted in the patient¿s forearm.
Event or Problem Description
It was reported that 3 of the bd nexiva¿ closed iv catheter system needls have gon through the catheter.Report 3 of 3.The following was received by the initial reporter: over the past week there have been 3 instances where the needles for our 1.75 inch peripheral ivs have cut through the catheters while inserting ultrasound guided ivs.The plastic catheter tip broke off and got lodged in the patients tissue.Additional information received on 09-aug-2023 the product lot # was 2300204 and ref # 383518 for the product that we kept the sample of.That is the correct batch number.The plastic catheter tip broke off and got lodged in the patients tissue.All instances of these catheters breaking have happened while performing ultrasound guided ivs.Additional information received on 14-aug-2023: 1.What was the patient outcome? - remains on inpatient ward.2.Was the catheter tip able to be removed? if so, how was it retrieved? - the tip has not been removed yet.3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? - an x-ray was done and the cannula was noted in the patient¿s forearm.
Additional Manufacturer Narrative
H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17604884
• Report Number: 1710034-2023-00940
• Device Sequence Number: 20373823
• Product Code: FOZ
• UDI-Device Identifier: 30382903835189
• UDI-Public: (01)30382903835189
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 383518
• Device Lot Number: 2300204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown