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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 use of the bd nexiva¿ closed iv catheter system after insertion blood was leaking from the self-sealing septum.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: mdr level a investigation: dhr review: all challenges and samples related to the complaint were performed successfully qn review: no issues were identified relating to the complaint during production of the batch eura review: causes of the defect idenified in the eura could not be confirmed without a sample.This incident does not exceed what is considered acceptable in the eura.Sample analysis (photo): the picture showed a drop form on the back of the septum assembly.The defect was confirmed through the investigation conclusion: the root cause was not identified during the investigation.

• 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: 7263509
• Report Number: 1710034-2018-00041
• Device Sequence Number: 1826705
• Product Code: FOZ
• UDI-Device Identifier: 30382903835400
• UDI-Public: 30382903835400
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K110443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018

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 Expiration Date: 02/28/2018
• Device Catalogue Number: 383540
• Device Lot Number: 5029832
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 03/23/2018
• 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