MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA; PERIPHERAL IV CATHETERS

Catalog Number 383519

Device Problem Defective Component (2292)

Patient Problem Discomfort (2330)

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd nexiva catheter is frayed.The following information was provided by the initial reporter: this iv was placed in a patient's vein causing great discomfort, the patient yelled out in pain and pulled their arm away, removing the iv.The end of the catheter on this iv appears to be frayed, which likely caused the discomfort.The patient required a second iv placement.I have the catheter at my desk for returning if needed.Thank you!.

• Brand Name: BD NEXIVA
• Type of Device: PERIPHERAL IV CATHETERS
• 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: 18120232
• MDR Text Key: 328504566
• Report Number: 1710034-2023-01306
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835196
• UDI-Public: (01)30382903835196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383519
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1