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

Catalog Number	381412
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard needle did not retract pulling catheter with it during process.The following information was provided by the initial reporter: attempting to start the patient's iv, iv was successfully started but when attempting to retract the needle to spring jammed and did not retract the needle or allow the needle to be removed from the iv catheter.While attempting to get the needle to retract the iv catheter was pulled out of the vein causing the patient to need another iv attempt other serious or important medical events.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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
A device history record review was completed by our quality engineer team for provided material number 381412 and lot number 4163937.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported issue, and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
Event or Problem Description
No additional information.

• Brand Name: BD 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: 22131350
• Report Number: 1710034-2025-00932
• Device Sequence Number: 17981105
• Product Code: FOZ
• UDI-Device Identifier: 00382903056033
• UDI-Public: (01)00382903056033(11)240621(10)4163937
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 381412
• Device Lot Number: 4163937
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown