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

Catalog Number 383539

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

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 the safety locking mechanism of the bd nexiva¿ closed iv catheter system did not lock.There was no report of injury or medical intervention.

Manufacturer Narrative

Results: one used sample and one unused sample were received for evaluation by our quality engineer team.Upon examination, the used unit was partially retracted.Through testing, both units were successfully disengaged with the cannula staying locked by the v-clip as intended.A luer-lok syringe was attached and flushed through the unit, all connections were secure and no leakage was observed.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defects.Conclusion: the root cause of the defect was not determined during the investigation as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7158048
• MDR Text Key: 96355488
• Report Number: 1710034-2017-00502
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835394
• UDI-Public: 30382903835394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 383539
• Device Lot Number: 6299940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other