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

Catalog Number	382544
Medical Device Problem Codes	Leak/Splash (1354); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.4.K201075; k251654.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
I have 2 more samples of defective iv catheters that i would like to send in.Do you have a formal complaint form or anything specific to fill out? additional info: only adverse event was that since the safety button stuck and the actual needle wouldn't retract without significant pressure; there was blood backflow that made a bloody mess/biohazard issue for staff and patient.Can you please provide an exact date of event? 03-03-2026.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaints of blood backflow and a stuck safety button or needle were confirmed based on the circumstantial evidence of the returned samples.Two insyte autoguard needles and one 18g insyte autoguard iv catheter were provided for investigation.The needles were received fully retracted within the safety shield.Blood residue was visible within the needle hub and on the external surface of the safety button.A functional test showed that the safety button was not sticking and the needles fully retracted when the safety mechanism was activated.Damage that was consistent with needle puncture damage was observed at the tip of the iv catheter.It is possible that the needle punctured the tubing, which may have caused a delay in retraction and allowed blood to leak from the blood control device.No other damage was observed on the returned samples.The exact cause of the damage could not be determined from the sample analysis.A review of the inspection records and quality and manufacturing controls for the implicated lot indicated no related 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.

• 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: 24718438
• Report Number: 1710034-2026-00342
• Device Sequence Number: 5727074
• Product Code: FOZ
• UDI-Device Identifier: 00382903825448
• UDI-Public: (01)00382903825448(17)280731(10)5233462
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 382544
• Device Lot Number: 5233462
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown