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

Catalog Number UNKNOWN

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Address information was not provided, therefore, xx was used as a place holder.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that an unspecified bd nexiva catheter is ballooning.The following information was provided by the initial reporter: they had an issue when power flushing that the j loop tubing expanded on the nexiva.They said the catheter was not kinked or meeting resistance.The piv was then removed.

Manufacturer Narrative

Investigation results: the complaint of expanded tubing on the 20g nexiva device was confirmed, but the root cause could not be determined from the photograph that was provided for investigation.The photo showed the nexiva device taped to the patient.A portion of the extension tubing was ballooned.This type of damage can occur if the catheter is kinked, obstructed, or pressurized beyond the pressure limit.Without the physical sample, the root cause could not be determined.The instructions for use (ifu) state, "avoid kinking or obstructing catheter during power injection.Warning: in the event of an occlusion, power injector pressure-limiting features may not prevent catheter failure." the ifu also states, "the 22-18 ga (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kpa) when access ports not suitable for use with power injectors are removed.".

• Brand Name: BD NEXIVA
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18626632
• MDR Text Key: 334389059
• Report Number: 1710034-2024-00059
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1