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

Catalog Number	381033
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
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 the needle did not retract.Complaint: the needle from the iv catheter would not deploy.Patient/hcp impact: not given.
Additional Manufacturer Narrative
E and f codes corrected our quality engineer inspected the sample submitted for evaluation.Your report of a damaged device was confirmed; however, the root cause could not be determined.One 20g insyte autoguard unit from lot #5316968 was provided for investigation.The needle was received protruding through the catheter tubing.This type of damage may occur at different stages throughout the manufacturing process or during clinical application.As the damage was verified outside its packaging, it could not be determined if the damage occurred during the tip adhesion break or during manufacturing.A functional test of the safety mechanism revealed that the needle fully retracted.No other damage or defects were identified on the returned samples.A device history record review showed no non-conformances 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.

• 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: 25095143
• Report Number: 1710034-2026-00494
• Device Sequence Number: 20042915
• Product Code: FOZ
• UDI-Device Identifier: 00382903810338
• UDI-Public: (01)00382903810338(11)251112(17)281031(10)5316968
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K251654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 381033
• Device Lot Number: 5316968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown