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

Catalog Number 383532

Device Problems Burst Container or Vessel (1074); Material Separation (1562)

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

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Device evaluated by mfr: 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 the bd nexiva¿ closed iv catheter system's extension tubing "burst" and separated from the cannula during use.The following information was provided by the initial reporter: "product has burst the extension tubing has come away from the cannula".

Manufacturer Narrative

H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the defect for evaluation.A review of the device history record was performed for the reported lot, 8304975, and no related quality issues were found during production.Our quality engineer reviewed the provided photo and determined that the extension tubing was disconnected from the winged adapter.Based off the provided photo the engineer was able to verify the reported issue.Without the physical sample available for investigation a definitive root cause could not be identified.However, this was a known issue for the manufacturing facility and it was determined that an insufficient amount of adhesive was being applied to the extension tubing and adapter port.This was causing a weak bond to form causing the tubing to become easily disconnected.Capa#684099 was initiated.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system's extension tubing "burst" and separated from the cannula during use.The following information was provided by the initial reporter: "product has burst the extension tubing has come away from the cannula".

• 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: 8549809
• MDR Text Key: 146405588
• Report Number: 1710034-2019-00448
• 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: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 383532
• Device Lot Number: 8304975
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other