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

Catalog Number 383519

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd nexiva¿ closed iv catheter system there was an issue with tubing defect. There was no report of injury or medical intervention.

Manufacturer Narrative

Received one 18ga nexiva unit within an open package from lot number 7286659. The needle-shield assembly was partially disengaged. A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of tubing damaged-defective-other with lot #7286659 regarding (b)(4). Dhr review shows a total of (b)(4) units were manufactured on nexiva line 1 starting on (b)(6) 2017 through (b)(6) 2017. 2 non-related qns (retraction failure) 200713406 and 200713575 were initiated during the production of the lot number associated with this incident. Disposition of the product, root cause and corrective action were applied according to the quality control plan. All other challenge, set-up and in process samples including (but not limited to) correct assembly and part air-water-leak test passed per specification. Visual evaluation of the unit revealed the end of the extension tube was not correctly inserted into the winged adapter port (kinked) and had left a partial gap of tubing out. This condition would cause leakage as experienced by the customer. This defect occurs during the manufacturing process on zone 8 at the adhesive dispense station if the catheter adapter is misaligned during the insertion of the extension tube. Current process controls include routine leak testing after zone 9 as well as a 100% online flow tester in zone 8. Customer complaint trends are evaluated on a monthly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

Event Description

It was reported with the use of the bd nexiva closed iv catheter system there was an issue with tubing defect. There was no report of injury or medical intervention.

• 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 ; 8015652845
• MDR Report Key: 7981723
• MDR Text Key: 124687147
• Report Number: 1710034-2018-00748
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161777
• 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,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 383519
• Device Lot Number: 7286659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/18/2018 Patient Sequence Number: 1