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

Catalog Number	381512
Medical Device Problem Code	Material Split, Cut or Torn (4008)
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
G.4.K201075; k251654.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E1.Address information was not provided; therefore, (b)(6) was used as the state.
Event or Problem Description
It was reported that the catheter split.There was also a recent incident where an iv was placed with a split in it; fortunately, it did not break off into the patient.The nurse felt something was off while threading it and noticed the split before administering anything and pulled it out right away.Additional information 3/11/2026: one event did reach the patient and the patient complained of pain at insertion site.Negative outcomes: wasted product, staff not trusting that a 24 g will work properly.Additional information 3/17/2026: due to regulatory reporting requirements, please provide which reported event date and lot number is associated with the one event that occurred/was noticed during the iv insertion process.Event date was 2/24/26.Insyte autoguard winged yel 24ga x.75in 381512, lot 5267948.
Additional Manufacturer Narrative
Our quality engineer inspected the photographs submitted for evaluation.Your report of a damaged catheter could not be confirmed from the two photographs that were provided for investigation.The observable features on the submitted images did not contain enough information or details to confirm the complaint or identify a specific root cause of the reported event.No damage or defects could be identified on the 24g insyte autoguard iv catheter that was shown in the photograph.Examination of the actual product involved may provide clarification as to the cause for the reported failure.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: 24652882
• Report Number: 1710034-2026-00304
• Device Sequence Number: 6109446
• Product Code: FOZ
• UDI-Device Identifier: 00382903815128
• UDI-Public: (01)00382903815128(11)240625(17)270531(10)4173309
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• 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: 381512
• Device Lot Number: 5267948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown