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

Catalog Number	381534
Medical Device Problem Codes	Material Puncture/Hole (1504); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
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 there was a hole in the catheter.¿when starting an 20g iv on a patient i got blood return, but the needle/catheter would not advance.Iv removed, hole noticed in tip of the catheter.¿ describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Had to restart iv because of hole in iv cath.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint needle puncture damage was confirmed for the four 20g insyte autoguard iv catheters that were provided for investigation.One iv catheter exhibited a v shaped breach with sharp edges near the tip of the catheter, which was consistent with needle puncture damage.The catheter damage was likely associated with the reported difficult advancement.Due to the evidence of use on the returned sample.The damage likely occurred during the insertion process.The instructions for use (ifu) indicate that the needle should not be re-inserted into the catheter if the needle is partially or completely withdrawn from the catheter tubing.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed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: 24518244
• Report Number: 1710034-2026-00225
• Device Sequence Number: 9724161
• Product Code: FOZ
• UDI-Device Identifier: 00382903815340
• UDI-Public: (01)00382903815340(10)5295475
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 381534
• Device Lot Number: 5295475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown