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	03/03/2026
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.B3.The date additional information was received by manufacturer has been used for this field.
Event or Problem Description
It was reported that the needle partially retracted.Upon insertion, tech went retract stilet, which would not retract.Response received on 3-mar-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 information received on 17-mar-2026: i was made aware that techs had experienced all 3 issue with the needle.I unfortunately was away from the site when the first 2 occurrences happened.
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.The investigation of those samples was documented in the investigation for the event from 17feb26.The lot number and samples of the other affected units that experienced needle partial retraction, slow retraction and no retraction were not provided for the investigation.Due to a trend of similar complaints, actions were taken to address these 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
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: 24648606
• Report Number: 1710034-2026-00299
• Device Sequence Number: 15901942
• Product Code: FOZ
• UDI-Device Identifier: 00382903810444
• UDI-Public: (01)00382903810444
• 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: Foreign,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: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown