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

Catalog Number	381823
Medical Device Problem Codes	Retraction Problem (1536); Material Protrusion/Extrusion (2979); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
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 needle pierced the catheter resulting in an inability to retract.Before inserting the needle, the nurse checked the catheter by pulling the needle out slightly.The catheter appeared normal.Once the needle was in the patient's vein, a slight swelling appeared under the patient's skin.No blood return.The nurse pulled the catheter out again.The catheter had been pierced by the needle and the needle would not retract.No adverse events affecting the patient were reported.Additional information 2/26/2026: the event took place on (b)(6) 2026.There were no consequences in the patient.
Additional Manufacturer Narrative
The complaint of complications during the insertion process was confirmed; however, the root cause could not be determined.One 22g insyte autoguard device was provided for investigation.The iv catheter was received separate from the needle, and the needle was received fully retracted within the safety shield.The sample exhibited evidence of use.A microscopic examination of the catheter revealed a v-shaped breach in the catheter tubing, which was consistent with needle puncture damage.The instructions for use (ifu) state, "if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur." the damage associated with the needle protruding through the catheter can affect flashback and needle retraction; however, the root cause of the reported issue could not be determined.There were no other similar complaints from the implicated lot.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.Manufacturing controls are in place to mitigate the occurrence of this type of failure.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: 24484838
• Report Number: 1710034-2026-00204
• Device Sequence Number: 20084443
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: (01)00382903818235(11)250324(17)280229(10)5057907
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 381823
• Device Lot Number: 5057907
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown