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

Catalog Number	381834
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.4.K201075; k251654 this mdr is the result of an investigation finding.Device evaluation: the complaint of separation of the needle from the catheter was confirmed; however, the root cause could not be determined.Two photographs and one 22g insyte autoguard device were provided for investigation.The 20g insyte autoguard iv catheter was received separate from the needle and the needle cover.One of the photographs showed the same sample condition.The photograph and physical sample showed the needle fully retracted within the safety shield.The iv catheter was not stuck in the needle cover.No misalignment between the catheter adapter and the needle cover was observed.Seeing how the sample was received with the needle already within the safety shield, it is more than likely the needle prematurely retracted.As the unit package had been opened, it could not be determined if the reported issue occurred during manufacturing or in the clinical setting.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.There were no other similar complaints from the implicated lot.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
This mdr is a result of an investigation finding.It was reported that when customer tried to remove the protective cap from the instrument, the outer tube was stuck and only the inner tube fell out before use.

• 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: 24714126
• Report Number: 1710034-2026-00332
• Device Sequence Number: 5726926
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: (01)00382903818341(11)250905(17)280630(10)5202518
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 381834
• Device Lot Number: 5202518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown