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

Catalog Number	381812
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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
Evidence of catheter (protector) perforated by the bevel.Outcome of the adverse event or incident: no harm.Detection of the adverse event/incident: during use of the md.Classification: non-serious adverse incident.
Additional Manufacturer Narrative
A device history record review was completed by our quality engineer team for provided material number: 381812 and lot number: 4249029.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported issue, 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.Based on the investigation results, an exact cause for this incident could not be identified.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint that the catheter was perforated by the needle was confirmed.One 24ga insyte autoguard unit from lot: 4249029 was provided for investigation.A microscopic examination revealed a v-shaped breach in the catheter tubing near the tip.The damage was reportedly detected during use.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The instructions for use (ifu) indicate to inspect device for damage before insertion and caution do not use if device is damaged.The ifu also indicates to not reinsert the needle into the catheter during the insertion process as damage may occur.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.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.
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: 23910150
• Report Number: 1710034-2025-01994
• Device Sequence Number: 13034738
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: (01)00382903818129(11)240910(17)270831(10)4249029
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2026

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: 381812
• Device Lot Number: 4249029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 03/18/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/15/2026; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female