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

Catalog Number	381412
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the iv start, the nurse inserted the catheter needle and, as it began entering the vein, the needle folded and punctured through the side of the catheter.The needle exited through the catheter wall while part of the catheter remained inside my vein.The nurse immediately retracted the device and applied pressure to stop the bleeding.Serious injury: no.
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
No new information.
Additional Manufacturer Narrative
The complaint that the needle pierced the iv catheter was confirmed and the cause appeared to be associated with use.Six photographs and five 24g insyte autoguard devices were provided for investigation.Four units were received in sealed unit packaging.No damage or defects were identified on the representative samples.The photos and open sample showed the needle protruding through the side of the 24g insyte autoguard iv catheter.The damaged sample exhibited evidence of use.Due to the presence of what appeared to be blood residue within the yellow adapter and between the catheter tip and the needle puncture site, it appeared that the catheter was able to access the vessel.The needle likely punctured the tubing after insertion.The instructions for use (ifu) state, "if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur." no defects associated with the manufacturing process could be identified from the photographs or returned samples.Manufacturing controls are in place to mitigate the occurrence of this type of failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received about 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 data collected for identification of emerging trends.

• Brand Name: INSYTE 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: 24579268
• Report Number: 1710034-2026-00264
• Device Sequence Number: 21140481
• Product Code: FOZ
• UDI-Device Identifier: 00382903814121
• UDI-Public: (01)00382903814121(10)5120118
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 381412
• Device Lot Number: 5120118
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown