MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT; PERIPHERAL IV CATHETERS

Catalog Number	383518
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd nexiva single port tubing ruptured.The following information was provided by the initial reporter: nexiva split vertically down the extension upon contrast injection.(b)(6) 2024 1.Is there any erroneous results/exposure to bodily fluid no exposure to bodily fluids.This was a newly inserted nexiva, placed by our vat immediately prior to administration of contrast.Brisk blood return at time of insertion as well as prior to contrast injection was noted & documented.2.Kindly confirm if any needle/probe stick injury /safety issue reported.No needle stick injury.Only safety issue is the potential for contrast extravasation or infusion of air via split in tubing.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint of a split in the extension tubing was confirmed from the two photographs that were provided for investigation.The photos showed a 20g nexiva unit with a longitudinal split in the extension tubing.The split and evidence of use were consistent with a rupture due to overpressurization.The instructions for use (ifu) provide instructions, warnings, and settings for power injection equipment to prevent catheter failure.Based on the reported event and the condition of the sample, the damage likely occurred during use.No defects associated with the manufacturing process could be confirmed from the photo; however, without the physical sample, the root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD NEXIVA SINGLE PORT
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18950555
• Report Number: 1710034-2024-00209
• Device Sequence Number: 7078343
• Product Code: FOZ
• UDI-Device Identifier: 00382903835188
• UDI-Public: (01)00382903835188
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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 Catalogue Number: 383518
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown