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

Catalog Number	381044
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
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
Tech went to insert iv.Upon insertion, tech went retract stilet, which would not retract.Additional information 3 mar 2026: could you please provide the exact event date (b)(6) 2026.Does the needle fail to retract? yes.If yes, does the needle partially retract, slowly retract, or not retract at all? we have all 3 occurrences happen.Is there any visible catheter damaged when it appears to be caught on the needle? nothing visible.Is there any harm/serious injury to patient? no.
Additional Manufacturer Narrative
The complaint of retraction issues was confirmed from the representative 18g insyte autoguard bc devices that were received in sealed unit packaging from lot #5156125.Although the affected units were not returned for investigation, a functional test of the returned samples revealed that the retraction time of some units exceeded the specification.Each needle fully retracted; however, one needle was briefly stuck within the catheter adapter before it retracted on its own.Due to the evidence observed on the returned samples, slow retraction and needle shielding failure were confirmed for units from lot #5156125.The lot number and samples of the other affected units were not provided by the customer.Due to a trend of similar complaints, actions were taken to address these issues.The appropriate manufacturing personnel were notified of this complaint.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: 24579559
• Report Number: 1710034-2026-00265
• Device Sequence Number: 9233706
• Product Code: FOZ
• UDI-Device Identifier: 00382903810444
• UDI-Public: (01)00382903810444(11)250605(17)280131(10)5156125
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K251654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare 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: 381044
• Device Lot Number: 5156125
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown