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

Model Number 383517

Device Problem Leak/Splash (1354)

Patient Problem Venipuncture (2129)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: the dhr for lot 9038938 has been reviewed.This lot was built and packaged on nfa line 1 from 08feb2019 through 12feb2019 for a quantity of (b)(4) units.No related quality issues or process deviations were found.Observations and testing could not be performed in the absence of a sample.Investigation conclusion: the defect leakage with power injector could not be refuted nor confirmed in the absence of a sample.Root cause description: the root cause cannot be determined for an unconfirmed defect.Rationale: customer complaint trends are evaluated on a monthly basis, however the need for a formal corrective action cannot be determined in the absence of the root cause.Risk to the end user is established based on occurrence and severity of the defect as related to a specific failure mode in the manufacturing process and the effects of that failure.The risk could not be evaluated for the unconfirmed defect in the absence of the root cause as there are multiple failure modes associated with the reported defect.

Event Description

It was reported that bd nexiva¿ closed iv catheter system experienced extravasation and the patient's blood was leaking.This was discovered during use.The following information was provided by the initial reporter: the patient underwent enhancement examination and intravenously injected contrast agent with indwelling needle on (b)(6) 2020.1.Contrast agent was extravasation 2.Patient's blood oozed from the adapter.

• Brand Name: BD NEXIVA CLOSED IV CATHETER SYSTEM
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10511852
• MDR Text Key: 206285786
• Report Number: 1710034-2020-00565
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: 30382903835172
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2020

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
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Model Number: 383517
• Device Catalogue Number: 383517
• Device Lot Number: 9038938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other