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

Catalog Number	382512
Medical Device Problem Codes	Product Quality Problem (1506); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record review was completed by our quality engineer team for provided material number 382512 and lot number 5210686.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.No sample movement was observed within 30 calendar days from the complaint open date.The investigation was concluded based on the information available to date.If samples are received later, the complaint may be reopened.Based on the investigation results, an exact cause for this incident could not be identified.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.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Catheter is flimsy on insertion additional information 1/28/26 any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No additional information 1/29/26 clarifies and confirms the need for this mdr: i have had the catheter shear several times when trying to thread the angiocath.

• 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: 24457462
• Report Number: 1710034-2026-00190
• Device Sequence Number: 9969319
• Product Code: FOZ
• UDI-Device Identifier: 00382903825127
• UDI-Public: (01)00382903825127(17)280731(10)5210686
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 382512
• Device Lot Number: 5210686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown