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

Catalog Number	382547
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
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
Visibly moldy iv catheter found in l&d [labor and delivery] supply.Package new and intact.Mold contained to inside of needle cap/hub, not suggesting external contamination (wet package, etc.).On (b)(6) 2025 customer response: 1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.1.None.2.Can you please provide an exact date of event in format dd-mmm-yyyy? 1.17-nov-2025.3.Total number of occurrences? 1.One.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Complaint review revealed that this is a duplicate complaint.Mdr was filed and captured under mfr report # 1710034-2025-01905.

• 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: 23923703
• Report Number: 1710034-2025-01999
• Device Sequence Number: 8825220
• Product Code: FOZ
• UDI-Device Identifier: 00382903825479
• UDI-Public: (01)00382903825479(17)280331(10)5105331
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 382547
• Device Lot Number: 5105331
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown