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

Catalog Number	381812
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
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 dirt/rust on the inside.After speaking with our nursing staff they confirmed it was about 10 cannulas that had similar problems and they advised that some that didn't have any visual issues were ¿sticky¿ and therefor also not useable.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Our quality engineer inspected the photographs submitted for evaluation.Your report of foreign matter on the insyte autoguard device was confirmed; however, the source and composition of the foreign matter could not be determined from the photograph that was provided for investigation.The photo showed two 24g insyte autoguard devices.One device appeared to be sealed.One device had been removed from its packaging and the needle cover had also been removed.A dark colored material was observed at the tip of the catheter and needle.Without the physical sample, no material analysis could be completed.A device history record review showed no non-conformances associated with this issue during the production of this batch.We appreciate you taking the time to bring this observation to our attention.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.

• 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: 24458217
• Report Number: 1710034-2026-00192
• Device Sequence Number: 21369439
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: (01)00382903818129(11)230828(17)260731(10)3237684
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K201075
• 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): 03/10/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 381812
• Device Lot Number: 3237684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown