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 Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 1 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.We have a picture of one and have kept a sample of another.
Event or Problem Description
It was reported that 3 of the bd nexiva¿ closed iv catheter system needls have gon through the catheter.Report 1 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.We have a picture of one and have kept a sample of another.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 23-aug-2023 h6: investigation summary our quality engineer inspected the sample and photographs submitted for evaluation.Bd received two photographs which displayed the cannula piercing through a 22g catheter tubing, and media is present in the device.The photographs do not appear to be related to the implicated 20g iv catheter that was returned for this investigation.The physical 20g sample was received retracted and decoupled with the needle slightly bent and the catheter tubing significantly damaged.The reported issue was confirmed.As the unit was used, it is unlikely that the damage occurred during manufacturing.Had the defect occurred during manufacturing, the condition of the catheter and needle would render the device unusable.The ifu(instructions for use) indicate that if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur.A needle spear through may also occur in the clinician setting during tip adhesion break or during venipuncture if the needle is advanced at a wrong angle or if the needle is moved up and down the catheter tubing.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: 17596672
• Report Number: 1710034-2023-00938
• Device Sequence Number: 20720917
• Product Code: FOZ
• UDI-Device Identifier: 30382903835189
• UDI-Public: (01)30382903835189
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,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?: No
• 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?: Device Returned to Manufacturer
• 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: 10/13/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown