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

Catalog Number 383532

Device Problems Leak/Splash (1354); Defective Device (2588)

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

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).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 port leaks after insertion with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter: i am the endoscopy manager, i want to notify you with regards to a faulty medical device the bd nexiva.It has been reported by my nurses that 3 cannulas have defective where the plastic port attached to the cannula falls apart during insertion.

Manufacturer Narrative

Investigation: a physical sample was not available for investigation but photos were provided for evaluation.A review of the device history record was performed for the reported lot, 8249758, and no quality issues were found during production.Our quality engineer reviewed the provided photos and determined that the extension tubing was disconnected from the winged adapter.Based off the provided photos the engineer was able to verify the reported defect.Even though a physical sample was not returned for inspection this was a known issue for the manufacturing facility.In previous investigations it was determined that an insufficient amount of adhesive was being applied to the tubing and adapter.The manufacturing facility has been notified of this incident and the findings.A corrective action, capa#684099, is underway to identify and correct this issue.

Event Description

It was reported that port leaks after insertion with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter: i am the endoscopy manager, i want to notify you with regards to a faulty medical device the bd nexiva.It has been reported by my nurses that 3 cannulas have defective where the plastic port attached to the cannula falls apart during insertion.

• 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
• MDR Report Key: 8555807
• MDR Text Key: 143590839
• Report Number: 1710034-2019-00458
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835325
• UDI-Public: 30382903835325
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 383532
• Device Lot Number: 8249758
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other