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

Catalog Number	381411
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle pierced the catheter.(this mdr represents unknown dates.) staff nurses have shared that many times when advancing the catheter, they are finding that the catheter shears on the needle.Was patient or end-user injured: n.When was incident noticed: prior to use (prior to use interpreted to indicate during the insertion process rather than during the infusion process) was incident discovered during direct patient care: n.Was any medical treatment required: n.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.G.4.K201075; k251654.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E1.Address information was not provided; therefore, il was used as the state.
Event or Problem Description
Customer response on 07-apr-2026.Please close this incident.It has already been resolved.

• Brand Name: INSYTE-N 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: 24802275
• Report Number: 1710034-2026-00384
• Device Sequence Number: 13128937
• Product Code: FOZ
• UDI-Device Identifier: 00382903814114
• UDI-Public: (01)00382903814114(11)251014(17)280930(10)5287386
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• 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): 04/15/2026

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: 381411
• Device Lot Number: 5287386
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown