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

Catalog Number	381912
Medical Device Problem Code	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
This mdr reflects additional information received on 3 mar 2026.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 the needle was slow to retract.Insyte autoguard inside the iv insertion kit issued in has been reported having a defect while they push the button for needle encapsulation of the catheter.They have mentioned that they have a hard time using it as it delays needle encapsulation which makes the button harder to press during insertion.03-mar-2026 - received an email response from complainant for information requested.Thank you for clarifying the details.Yes, it was indeed under material code 381912.All (b)(4) items were used to different patients.
Additional Manufacturer Narrative
Correction: the aware date was incorrectly entered in the initial mdr.Device evaluation: the complaint of delayed needle retraction was confirmed, and the cause appeared to be manufacturing related.One video and two fully retracted needles were provided for investigation.Examination and functional testing of the returned samples was performed.No defects or abnormalities were observed.The video showed the activation of the safety mechanism after the iv catheter had been removed from the needle.The retraction time of the needle exceeded the specification, which was likely caused by excess or dispersed gel.A trend has been identified for the reported failure and further actions have been initiated to investigate this type of incident and address the manufacturing root cause.No additional action will be taken at this time.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 additional 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: 24688974
• Report Number: 1710034-2026-00325
• Device Sequence Number: 9653494
• Product Code: FOZ
• UDI-Device Identifier: 00382903819126
• UDI-Public: (01)00382903819126(11)250122(17)271231(10)5017280
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 03/26/2026

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: 381912
• Device Lot Number: 5017280
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown