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

Catalog Number	382623
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Address information was not provided; therefore, (b)(6) was used as the state.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
It was reported that the needle slipped retraction after retraction."rn pushed white button to retract the needle after iv was placed.Rn placed the retracted needle piece on patient's bed after iv placement.When placing needle piece on bed, needle ejected.Neither staff nor patient was harmed.".
Additional Manufacturer Narrative
Investigation summary: root cause couldn't be determined due to unavailability of sample information.A complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of safety shield activation failure (catheter) with lot 5339236 regarding item 382623.Dhr number 5339236 has been reviewed.No related quality issues or process deviations were found during the manufacture of the subassembly lot and packaging line.A review of the applicable risk documents indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Additional information received and added to b.1.Describe event or problem.
Event or Problem Description
Additional information: 9-apr-2026: did the needle initially completely retract? and then came out of the housing again when it was set down? good morning, yes, that it correct.

• 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: 24767370
• Report Number: 1710034-2026-00366
• Device Sequence Number: 9247897
• Product Code: FOZ
• UDI-Device Identifier: 00382903826230
• UDI-Public: (01)00382903826230(11)251210(17)281130(10)5339236
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

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: 382623
• Device Lot Number: 5339236
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 04/15/2026; Not provided
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/15/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown