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

Catalog Number	381512
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
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 bd insyte autoguard winged leaked at the catheter/hub junction.The following information was provided by the initial reporter: this rn opened 24 g 0.75 inch piv package as normal, did not loosen or remove catheter from needle at all.This rn placed peripheral catheter in right, distal saph.Before flushing, rn noted blood to be pooling at the insertion site.Area cleaned, then piv flushed, more blood came from site.Catheter slightly pulled back and it was noted that blood was beading out of the catheter near the point where the catheter meets the hub.Piv removed and bleeding controlled.Piv was flushed into the sink and it was noted again that saline was beading out of the catheter near the hub.(b)(6) 2025 no serious harm.The patient had to have an additional catheter placed.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint of a leak from the iv catheter was confirmed; however, the root cause could not be determined.One 24g insyte autoguard iv catheter was returned for investigation.The sample exhibited evidence of use.What appeared to be blood residue was visible on the catheter adapter.A functional test revealed a leak from the catheter tubing near the nose of the adapter.A microscopic examination revealed a curved breach in the tubing.As the device has been opened, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.There were no distinguishing features which could aid in identification of a specific root cause.No other similar complaints were reported from the implicated lot.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• 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: 22479674
• Report Number: 1710034-2025-01173
• Device Sequence Number: 20843241
• Product Code: FOZ
• UDI-Device Identifier: 00382903815128
• UDI-Public: (01)00382903815128(11)250117(17)271231(10)5010460
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 5010460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown