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

Catalog Number	381423
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard needle pierced the catheter.The following information was provided by the initial reporter: i am reporting the following event that occurred on (b)(6) 2025.22g piv catheter torn through by needle, causing a failed attempt on pt due to the catheter not being secured around needle.Seems to be manufacturing error during placement of catheter on iv needle.
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
No additional information.
Additional Manufacturer Narrative
Correction: material/lot # information was clarified/verified and updated in the complaint.
Additional Manufacturer Narrative
Our quality engineer inspected the photographs and sample submitted for evaluation.Your report that the needle perforated the catheter was confirmed and the cause appeared to be associated with use.Three photographs were provided for investigation, which showed a 22g insyte autoguard device with the needle protruding through the side of the catheter tubing.The sample exhibited evidence of use, which indicates that the needle was likely withdrawn from the iv catheter and reinserted into the catheter after the vessel was accessed.The instructions for use (ifu) indicate to not reinsert the needle into the catheter during the insertion process as damage may occur.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: 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: 22689598
• Report Number: 1710034-2025-01273
• Device Sequence Number: 8250770
• Product Code: FOZ
• UDI-Device Identifier: 00382903814374
• UDI-Public: (01)00382903814374(10)4330107
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2025

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: 381423
• Device Lot Number: 4330107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: Not provided; 09/15/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/04/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown