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

Catalog Number	383540
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
"it was reported during the injection, that while using the injection pump, the bd nexiva¿ closed iv catheter system there had loss of contrast and saline solution through the route of material that was free, even using a valve according to the manufacturer's instructions.The event occurred during the coronary angiography." no reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Investigation summary: the defective unit was not received for evaluation and testing.Root cause is indeterminate.Dhr review - a review of the dhr could not be performed as no batch number was provided.Investigation conclusion: no sample was received for evaluation or testing.The customer's experience could not be confirmed or reproduced.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7555152
• Report Number: 1710034-2018-00247
• Device Sequence Number: 10804956
• Product Code: FOZ
• UDI-Device Identifier: 00382903835409
• UDI-Public: 00382903835409
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

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 Catalogue Number: 383540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 06/01/2018
• 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