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

Catalog Number	381444
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard crack in hub with blood leak.The following information was provided by the initial reporter: when the iv catheter was inserted into the patient it started leaking blood around the green hub part of the catheter.It was discovered that the green hub had a crack through it.Customer response on (b)(6) 2025.Can you please provide an exact date of event? 02-17-25 describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Patient required a second venipuncture to be performed due to failure of the initial catheter.
Additional Manufacturer Narrative
D.Potential lot (batch) #s provided: our best guess is either lot # 4222173 or 4310980 based on unused product in storage.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
Investigation results: our quality engineer inspected the sample submitted for evaluation.Your report of a leak was confirmed, and the cause was attributable to a circumferential crack in the green catheter adapter, which appeared to be manufacturing related.The adapter was intact and in one piece; however, the adapter was broken, and the plane of the break was adjacent to the push tab.
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: 21509717
• Report Number: 1710034-2025-00349
• Device Sequence Number: 4448914
• Product Code: FOZ
• UDI-Device Identifier: 00382903814442
• UDI-Public: (01)00382903814442
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 381444
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 05/01/2025
• 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