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

Catalog Number	382644
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Xxxxx had an 18g iv that needled wouldn't retract on when he pressed the button, he then went to just pull the needle out and it shredded the catheter.Customer response on (b)(6): yes, i think it was the 8th, i explained everything in detail, face-to-face, to your company rep on site the next day.The needle didn't move at all when i pushed the button.I had to manually pull the needle out while at the same time reaching with my other hand to push down and include the vein/catheter because it was bleeding everywhere from the self occlusion malfunctioning.
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.
Additional Manufacturer Narrative
No photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 382644 and lot number 5093073.A quality notification related to the reported defect of needle retraction failure was initiated during the build of this lot, and quality notification review (qn) could not be performed for the defect of needle through catheter.However, without a sample we cannot confirm that this failure was related to that notification.Based on the available information, an exact cause for this incident could not be identified.
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: 23903519
• Report Number: 1710034-2025-01987
• Device Sequence Number: 9360339
• Product Code: FOZ
• UDI-Device Identifier: 00382903826445
• UDI-Public: (01)00382903826445(17)280331(10)5093073
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 382644
• Device Lot Number: 5093073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/28/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown