MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA 20 GA X 1.25IN SP WITH MAXZERO; PERIPHERAL IV CATHETER

Catalog Number 383557

Device Problem Material Separation (1562)

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

Event Date 03/21/2024

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

Event Description

It was reported that bd nexiva 20 ga x 1.25in sp with maxzero tubing separated from adapter.The following information was provided by the initial reporter: the extension set fell off of nexiva right as it connects at the wings.There have been several of these same exact failures in the past couple weeks.Always the nexiva 20g x 1.25" sp w.Mz.

Event Description

Ack sent follow up for sample with additional questions 1.Mentioned as 3 different lots are reported so far.Kindly provide all the lot numbers 2.It will be helpful if a precise number of occurrences is available.Please provide if possible.3.Please describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.(if any).All of the incidents have been reported with a product incident report.All lot information has been provided if available on each pir.So far, i have lot #3320154, 3320156, and 3153954.To date, hendricks has reported about 5 or 6 of these same experiences with the extension set coming off at the wings.

Manufacturer Narrative

A device history record review was completed by our quality engineer team for provided material number 383557 and lot number 3153954 & 3320156.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD NEXIVA 20 GA X 1.25IN SP WITH MAXZERO
• Type of Device: PERIPHERAL IV 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: 19087159
• MDR Text Key: 340576024
• Report Number: 1710034-2024-00322
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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: Other
• Device Catalogue Number: 383557
• Device Lot Number: 3153954
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/24/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1