MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE-N AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number	381411
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our quality engineer inspected the photograph submitted for evaluation.Your report of a damaged catheter could not be confirmed from the representative 24g insyte autoguard devices that were provided for investigation.Thirtyfive units from the implicated lot were received and subjected to gross visual inspection, which found all units sealed in original packaging with no visible physical damage.A functional test to simulate the needle tip penetration, catheter tip penetration, and catheter drag revealed that the measured forces were within specification.All evaluated units met applicable specifications, and no damage or anomalies associated with the reported condition were observed.A device history record review showed no nonconformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No new information.
Additional 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 or Problem Description
It was reported that catheter is shearing.Catheters shearing.Additional information 6 mar 2026: the catheters appeared intact before poking.Once the catheter punctured the skin, the plastic immediately sheered and you were not able to advance.Total number of occurrences? i know of at least 4 incidences in nic 1 over 24 hours.I have heard that others also had issuse but hadn't reported them.In addition to the 4 nicu in 24 hours, prior to that there had been a handful of incidences starting the weekend before (2/21-2/22).These were discovered after asking frequent inserters if they have had issues.All of the inserters had the same reaction saying "yes! i thought it was just me." other instances i have documented are 2 sheering 2/23, and at least 2 on 2/27 from our pediatric ed.
Additional Manufacturer Narrative
Additional information added to b tab.Annex e and f codes updated.
Event or Problem Description
Additional information: 30-mar-2026: there was not harm to the patients other than requiring an additional poke to obtain peripheral access.

• Brand Name: INSYTE-N AUTOGUARD
• Common Device Name: 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: 24715795
• Report Number: 1710034-2026-00341
• Device Sequence Number: 5763659
• Product Code: FOZ
• UDI-Device Identifier: 00382903814114
• UDI-Public: (01)00382903814114(11)251014(17)280930(10)5287386
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381411
• Device Lot Number: 5287386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 03/31/2026; Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 03/31/2026; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown