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

Catalog Number 383513

Device Problems Material Separation (1562); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd nexiva¿ closed iv catheter system customer unable to flush and found the tubing was defective.The following was received from the initial reporter: pivc was inserted into pt but we were unable to flush the line or get any blood return.Pivc was removed and noted to have an area inside the tubing near the wings that is actually not connected to itself.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: (b)(6) 2023 h6: investigation summary our quality engineer inspected the 1 photo and 1 sample submitted for evaluation.The reported issue of separation inserter from tubing was not confirmed but the failure mode of flow rate slow/occluded was confirmed upon inspection of the sample.Analysis of the sample under a microscope showed that there was an occlusion at the junction of the tube and the port of the catheter adapter.The sample underwent flow testing and failed, with no flow through the sample.Bd determined that the cause of the failure was likely a result of manufacturing personnel failure during our manual segregation process for removing bad components from the final stages of manufacturing.A quality alert was created to inform the manufacturing personnel of the final assembly process of the reported defect.Production records were reviewed, and this batch meets our manufacturing specification requirements.H3 other text : see h10.

Event Description

It was reported that while using the bd nexiva¿ closed iv catheter system cusotmer unable to flush and found the tubing was defective.The following was received from the initial reporter: pivc was inserted into pt but we were unable to flush the line or get any blood return.Pivc was removed and noted to have an area inside the tubing near the wings that is actually not connected to itself.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17580664
• MDR Text Key: 321628262
• Report Number: 1710034-2023-00931
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835134
• UDI-Public: (01)30382903835134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 383513
• Device Lot Number: 3111293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• 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