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

Catalog Number	381444
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Injuries or adverse event: no.Reported issue: customer explained they use 6 out of the 25.Blood spilled out and the auto aclusion failed.
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
Additional follow up sent on 24sep2025: the initial report indicated that 'blood spilled out and the auto occlusion failed.' however, upon review, our investigation team has confirmed that the referenced material# 381444 is a non-blood control device.Kindly confirm whether you were aware of this information.Customer response received on 24sep2025.We were unaware that these do not have a blood control feature.The client explained that other time they had used it the blood did not spill out.
Additional Manufacturer Narrative
Additional information received: the initial report indicated that 'blood spilled out and the auto occlusion failed.' however, upon review, our investigation team has confirmed that the referenced material# 381444 is a non-blood control device.Correction- cancel mdr.There is no failure related to bc as this device does not have that feature.

• 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: 23101688
• Report Number: 1710034-2025-01541
• Device Sequence Number: 8617704
• Product Code: FOZ
• UDI-Device Identifier: 00382903814442
• UDI-Public: (01)00382903814442(10)5111218
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: 5111218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown