MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD IAG BC PRO GLOBAL; PERIPHERAL IV CATHETERS

Catalog Number	381012
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
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
It was reported that bd iag bc pro global leaked beyond the blood control.The following information was provided by the initial reporter: i¿m a clinical engineer working for (b)(6).(b)(6) and i was looking to submit a complaint against an insyte autoguard iv catheter as at least two of the same lot#¿s had faults regarding to the blood flow control one-way valve.When the catheter was inserted, the blood would flow from the cannula.I tried using this resource from your website complaint reporting | bd but it looks like the links are dead.Any injuries and/or harm? no harm incident but potential risk for rn due to blood exposure.What is the issue you experienced? product is functional otherwise but blood control valve faulty, allowing blood to flow from cannula on peripheral insertion.
Additional Manufacturer Narrative
Our quality engineer inspected the photographs submitted for evaluation.Your report of leakage through the blood control valve could not be confirmed from the two images that were provided for investigation.One photograph showed the top web label from a 24g insyte autoguard bc unit package.The other image was a screenshot from the bd website.It appeared that the image was used to demonstrate the reported issue.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
No new information.

• Brand Name: BD IAG BC PRO GLOBAL
• 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: 22534078
• Report Number: 1710034-2025-01201
• Device Sequence Number: 7488032
• Product Code: FOZ
• UDI-Device Identifier: 00382903810123
• UDI-Public: (01)00382903810123
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 381012
• Device Lot Number: 5045778
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown