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

Catalog Number	381012
Medical Device Problem Codes	Leak/Splash (1354); Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As per the customer report, there was a hole in the side of the hub and blood leaked out during use.
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.E.1.Characters limit is exceeded at facility name: (b)(6).
Additional Manufacturer Narrative
Our quality engineer inspected the photographs and sample submitted for evaluation.Your report of leakage from the catheter adapter was confirmed and the cause appeared to be manufacturing related.Four photographs and one 24g insyte autoguard iv catheter were returned for investigation.The sample exhibited evidence of use.A microscopic examination revealed a void in the catheter adapter, from which fluid was able to leak.The yellow material of the adapter was rounded inward at the breach, which appeared to be consistent with molding damage.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.
Event or Problem Description
No new information.

• 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: 23837950
• Report Number: 1710034-2025-01967
• Device Sequence Number: 12010212
• Product Code: FOZ
• UDI-Device Identifier: 00382903810123
• UDI-Public: (01)00382903810123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 381012
• Device Lot Number: 4004581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown