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

Catalog Number 383557

Device Problem Material Separation (1562)

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

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd nexiva sp with maxzero tubing separated from hub.The following information was provided by the initial reporter: the extension set fell out of the wings of nexiva.This is the 7th time this same failure has occurred.Customer response for follow-up: describe any patient harm, injury, complication, or negative outcome that occurred because of the event.There was no patient harm other than it required an iv to be reestablished for access.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: the complaint that the extension tubing separated from the catheter adapter was confirmed and the cause appeared to be manufacturing related.Two 20g nexiva catheters were returned for investigation.One unit was received in sealed packaging and exhibited no damage or defects.The adhesive was found to be placed in the correct location.The unit that was received in open packaging exhibited misplaced adhesive, which likely allowed the extension tubing to separate from the catheter adapter with minimal stress.The appropriate manufacturing personnel were notified of this complaint.A device history review was conducted for lot number 3320154.Our records show that this is the only instance of this issue occurring in this production batch.Complaints received for this product and condition will continue to be tracked and trended.

• Brand Name: BD NEXIVA SP WITH MAXZERO
• 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: 19085401
• MDR Text Key: 340565975
• Report Number: 1710034-2024-00318
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835577
• UDI-Public: (01)00382903835577
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: 383557
• Device Lot Number: 3320154
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1