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

Catalog Number	381044
Medical Device Problem Codes	Leak/Splash (1354); Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2026
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 the blood simply runs out.
Additional Manufacturer Narrative
Our quality engineer inspected the samples submitted for evaluation.Your report of "slow backflow" or leakage could not be confirmed from the representative 18g insyte autoguard bc units that were provided for investigation.A functional test revealed no flashback issues and the blood escape time was within specification.The "recoil is very slow" was confirmed from the physical samples that were provided for investigation.When retracting the needles, variable retraction times were detected.A functional test showed that the needle retraction time of one unit exceeded the specification.A slow retraction may cause the needle to get caught in the septum and result in leakage beyond the septum during use so the complaint of needle retraction slow was confirmed.A device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend has been identified for the reported slow retraction failure and corrective actions have been initiated to investigate this type of incident and identity the root cause.Complaints received for this device and reported condition will continue to be tracked and trended.The appropriate manufacturing personnel have been notified.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 additional information was provided.

• 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: 24401059
• Report Number: 1710034-2026-00166
• Device Sequence Number: 9730442
• Product Code: FOZ
• UDI-Device Identifier: 00382903810444
• UDI-Public: (01)00382903810444(11)250430(17)280331(10)5118145
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K251654
• 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 Catalogue Number: 381044
• Device Lot Number: 5118145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown