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

Catalog Number 383536

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/02/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd nexiva¿ closed iv catheter system with dual port had a y-site that could not be tightened.

Manufacturer Narrative

Investigation summary: received one q-syte assembly with no packaging material.The nexiva unit related to this investigation was not returned for evaluation.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of adapter / connector defective / damaged with lot #8208729 regarding item #383536.Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed qn (b)(4)(extension tubing bond strength oos) was initiated during the build of this lot that could impact the outcome of the quality of the product relevant to the defect stated in the pir.(b)(4) (difficult retraction), (b)(4) (incomplete seal) and (b)(4) (suspect splice tape top web) were also initiated during the build of this lot number.Investigation conclusion: the returned q-syte unit did not display any adverse characteristics that would contribute to the defect the described in the event description.No physical-mechanical damage was visible on the q-syte assembly.The failure could not be confirmed or replicated in the laboratory.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.

Event Description

It was reported that a bd nexiva¿ closed iv catheter system with dual port had a y-site that could not be tightened.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL 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: 8092436
• MDR Text Key: 128070022
• Report Number: 1710034-2018-00839
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: 30382903835363
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 383536
• Device Lot Number: 8208729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other