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

Catalog Number 383512

Device Problem Crack (1135)

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

Event Date 02/24/2024

Event Type  malfunction  

Event Description

It was reported that bd nexiva single port luer connector cracked.The following information was provided by the initial reporter, translated from chinese to english: the head nurse reported that during the use of the product, the luer connector cracked after the indwelling needle was inserted for about 6 hours.The affected quantity is 2.Green claims are required, a complaint reply letter is required, and a complaint acceptance letter is required.Samples can be returned and photos can be provided.

Manufacturer Narrative

Reported address does not fit: (b)(6).H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

• Brand Name: BD NEXIVA SINGLE PORT
• 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: 18920521
• MDR Text Key: 337855264
• Report Number: 1710034-2024-00193
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835127
• UDI-Public: (01)30382903835127
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383512
• Device Lot Number: 2306109
• Date Manufacturer Received: 02/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1