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

Catalog Number	383537
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that before use of the bd nexiva¿ closed iv catheter system there is a piece of fuzz stuck on the catheter.
Additional Manufacturer Narrative
H.6.Investigation: during dhr review all required challenge samples, set-up and in process testing was performed in accordance with the quality plan.No quality notifications were initiated during production received a 20ga nexiva unit within an open package from lot number 8256703.All the components were intact.No physical ¿mechanical damage was observed on the catheter tubing and the tip was acceptable per specification.The catheter tubing revealed traces of lube (non-foreign) material (which is part of the manufacturing process-tipping).No foreign material or plastic was observed on the unit.The lube quickly dissolved upon manipulation.The non-foreign matter (lube) observed in this investigation for this incident was introduced to the unit during the manufacturing process and would not affect fit, form or function of the product.No physical ¿mechanical damage was observed on the catheter tubing and the tip was acceptable per specification.H3 other text : see h.10.
Event or Problem Description
It was reported that before use of the bd nexiva¿ closed iv catheter system there is a piece of fuzz stuck on the catheter.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8404546
• Report Number: 1710034-2019-00275
• Device Sequence Number: 13550550
• Product Code: FOZ
• UDI-Device Identifier: 30382903057864
• UDI-Public: 30382903057864
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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
• Operator of Device: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 383537
• Device Lot Number: 8256703
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other