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

Catalog Number	381812
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Blood sampling was performed as clinically indicated.A peripheral intravenous catheter (pivc) was inserted by the nurse.No blood return was observed following insertion.The pivc was then removed, and inspection revealed that the soft cannula had split.The split cannula was identified as the cause of the absence of blood return.Immediate actions taken: the pivc was removed immediately upon noting the absence of blood return.The damaged cannula was inspected and retained for documentation.Patient condition was assessed; no immediate complications were observed.Patient outcome: no immediate adverse physiological response noted at the time of the event.05-feb-2026 - received an email response from complainant for information requested.1.Is there any serious injury happened to patient? it was mentioned in pir was unknown.2.Are there any potential erroneous results? it was mentioned in pir was unknown.3.What course of treatment changed due to event? it was mentioned in pir was unknown.4.What medical int.Other than first aid taken due to event? it was mentioned in pir was unknown.5.What safety issue taken due to event? it was mentioned in pir was unknown.6.Kindly provide the sample tracking details.7.Kindly provide the event occurrence date regarding items 1 to 4, the answers are no ¿ none of these situations occurred.For item 5, there was no blood return, so the procedure was stopped immediately, and a new, unused device was used to complete the remaining steps.The event occurred on february 2.
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.
Additional Manufacturer Narrative
Investigation results: root cause couldn't be determined due to unavailability of sample information.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of catheter broke/separated after placement with lot #5142871 regarding item #381812.No quality issues or process deviations were found.A review of the applicable risk documents indicate that the potential risk of the reported event was assessed appropriately in the risk management documentation.
Event or Problem Description
No additional 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: 24283817
• Report Number: 1710034-2026-00115
• Device Sequence Number: 21314087
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: (01)00382903818129(11)250722(17)280430(10)5142871
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 381812
• Device Lot Number: 5142871
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown