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

Catalog Number	382623
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer was not able to provide specific dates for events.One mdr only due to this.G.4.K201075; k251654.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
It was reported that there were connection issues that led to leakage.We have been having difficulty with the connection between the iv catheter and the saline lock seating properly and leaking.They have either had to really force it together or restart the patient's iv; this has happened about a half a dozen times in the last couple of days and additional times in the last few weeks.Additional information 4/3/2026: can you please provide an exact date of event? dates starting (b)(6) 2026 (issue of multiple occurrences reported on (b)(6) 2026 and lot was able to be replaced 3/30/26).What was the impact to the patient? for the most part, the connect would leak slightly and forcibly tightened to minimize the leak.On one occasion, the iv could not be salvaged and needed to be restarted due to the catheter connection leak not being able to be managed.You mentioned that this issue has occurred approximately half a dozen times over the past couple of days, as well as additional times in the past few weeks.If so, could you please provide the date of each occurrence, indicate whether there was any patient impact, and advise whether the issue occurred with any other lot numbers? issue did not occur with any other lot numbers, affected dates were included (b)(6) 2026.Daily issues with the connect would leak slightly and forcibly tightened to minimize the leak.On one occasion, the iv could not be salvaged and needed to be restarted due to the catheter connection leak not being able to be managed ((b)(6) 2026).
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint of a leak could not be confirmed from the representative 22g insyte autoguard units that were received in sealed packaging from lot #5339236.A functional test, visual examination, and microscopic examination of the returned samples revealed no leaks or damage.The affected unit was not provided for investigation.Although the representative samples and manufacturing records do not support the complainant¿s description of the reported event, 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.

• 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: 24875266
• Report Number: 1710034-2026-00415
• Device Sequence Number: 10002373
• Product Code: FOZ
• UDI-Device Identifier: 00382903826230
• UDI-Public: (01)00382903826230(17)281130(10)5339236
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/24/2026

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: 382623
• Device Lot Number: 5339236
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown