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

Catalog Number 383520

Device Problem Sticking (1597)

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

Event Date 04/10/2018

Event Type  malfunction  

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 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 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.

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 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.

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
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7492246
• MDR Text Key: 107697316
• Report Number: 1710034-2018-00220
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835201
• UDI-Public: 00382903835201
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 383520
• Device Lot Number: 7192532
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 04/18/2018
• Supplement Dates FDA Received: 07/05/2018; 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other