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

Model Number 383536

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Exposure to Body Fluids (1745); Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2022

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 the bd nexiva¿ closed iv catheter system blew apart and leaked.The following information was provided by the initial reporter: this is the third time this has happened in the past week and on one occasion the tubing actually blew apart and the techs has an awful mess of blood & contrast to clean up.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed the label of the unit indicating a 20g x 1.00in.Nexiva from lot number 2165231.The other photo shows a used nexiva unit with the clamp engaged.A portion of the extension tubing near the connection with the catheter adapter appears to be expanded resulting in an abnormally large diameter for the extension tubing.There were no tears observed on the extension tubing.The reported issue was confirmed.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.During manufacturing, a ballooned tubing (as seen on this unit) may result from an occlusion due to excess adhesive between the catheter adapter and extension tubing.During use, ballooning may occur due to a kinked, occluded, or obstructed tubing.It may also be caused by exceeding the maximum power injection pressure of 300psi.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system blew apart and leaked.The following information was provided by the initial reporter: this is the third time this has happened in the past week and on one occasion the tubing actually blew apart and the techs has an awful mess of blood & contrast to clean up.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVENOUS 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15505588
• MDR Text Key: 305515469
• Report Number: 1710034-2022-00561
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: (01)30382903835363
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383536
• Device Catalogue Number: 383536
• Device Lot Number: 2165231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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