MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD¿ NEXIVA; PERIPHERAL VASCULAR CATHETER

Catalog Number 383516

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 extension tubing of bd¿ nexiva was fallen off the catheter during use.

Manufacturer Narrative

Investigation: during dhr review all required challenge samples, set-up and in process testing was performed in accordance with the quality plan.Review disclosed three non-related qn¿s were initiated during build of this lot that not would impact the outcome of the quality of the product relevant to the defect.Received a 20ga nexiva extension set and catheter-adapter assembly, along with a fully disengaged needle-grip assembly and an open package from lot number 8177954.Visual examination: traces of patient residue was observed throughout the components.The extension tubing was disconnected from the port of the winged adapter.Traces of adhesive residue were present on the outer rim of the wing adapter port.The failure mode of detached extension tubing was caused by an insufficient amount of adhesive dispensed to fully bond the tubing to the catheter adapter.Capa 684099 has been initiated to further investigate this issue.

Event Description

It was reported that a extension tubing of bd¿ nexiva was fallen off the catheter during use.

• Brand Name: BD¿ NEXIVA
• Type of Device: PERIPHERAL VASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8204437
• MDR Text Key: 131704765
• Report Number: 1710034-2018-00953
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835165
• UDI-Public: 30382903835165
• Combination Product (y/n): N
• PMA/PMN Number: K102520
• 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: 04/12/2019

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: 05/31/2021
• Device Catalogue Number: 383516
• Device Lot Number: 8177954
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other