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

Catalog Number	383520
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 there was a difficult hub disengagement when using a bd nexiva¿ closed iv catheter system single port.There was no report of exposure, injury or medical intervention.
Event or Problem Description
It was reported that there was a difficult hub disengagement when using a bd nexiva¿ closed iv catheter system single port.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: no sample was returned for evaluation.Dhr review - no issues related to the defect were identified during production.Qn review - no qns were initiated due to issues found in production.Causes of the defect are tooling misalignments during assembly.Without the samples the defect could not be confirmed.The occurrence of this incident does not exceed what is acceptable.The severity is limited and the occurrence is low.No actions will be taken at this time.
Event or Problem Description
It was reported that there was a difficult hub disengagement when using a bd nexiva¿ closed iv catheter system single port.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SINGLE PORT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7492246
• Report Number: 1710034-2018-00220
• Device Sequence Number: 1677708
• Product Code: FOZ
• UDI-Device Identifier: 00382903835201
• UDI-Public: 00382903835201
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/20/2018

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: 06/30/2020
• Device Catalogue Number: 383520
• Device Lot Number: 7192532
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018; 04/18/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 07/05/2018; 09/07/2018
• 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