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

Catalog Number	381423
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
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 partial needle retraction occurred.Reported issue per customer: customer stating faulty catheters - we observed two incidents where it failed to retract the needle safely.Please provide an exact date of event in format mm-dd-yyyy? 02-09-2026.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Unknown patient harm or injury.
Additional Manufacturer Narrative
The complaint that the needle failed to fully retract was confirmed; however, the root cause could not be determined.One photograph was provided for investigation, which showed an insyte autoguard needle that was partially retracted.The needle tip remained extended from the shield because the needle hub would not fully retract.The barrel component of the shield was cracked, which likely prevented the needle hub from fully retracting.As the device had been used, it could not be determined with certainty whether the damage originated during manufacturing, storage, or use of the device.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.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: 24524737
• Report Number: 1710034-2026-00229
• Device Sequence Number: 18273379
• Product Code: FOZ
• UDI-Device Identifier: 00382903814237
• UDI-Public: (01)00382903814237(11)250515(17)280430(10)5135740
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/19/2026

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: 381423
• Device Lot Number: 5135740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown