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

Catalog Number	382537
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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
"needle used to start iv is going through the plastic catheter.This is happening on both product number listed and has happened at least 4 times in the past but bad product was disposed." (b)(6) 2025: 1.Can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6) 2025 this is the date reported, not sure of the other dates noted in the past.2.It was mentioned as "happened at least 4 times in the past" was it occurred on same date with same material # and lot#? kindly provide information.Not available.3.What was the impact to the patient? any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No injury reported.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.Your reported issue that the needle was going through the catheter was confirmed and the damage appeared to be associated with use.One 20g insyte autoguard device from lot 4325718 was provided for investigation.The sample exhibited evidence of use.The needle was protruding through the catheter tubing.Due to the presence of what appeared to be blood residue between the catheter tip and the needle puncture site, it appeared that the catheter tubing was able to access the vessel.The needle likely punctured the tubing after insertion.The instructions for use (ifu) state, "if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur."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 AUTOG BC
• 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: 22974094
• Report Number: 1710034-2025-01460
• Device Sequence Number: 9429940
• Product Code: FOZ
• UDI-Device Identifier: 00382903825370
• UDI-Public: (01)00382903825370(17)271031(10)4325718
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 382537
• Device Lot Number: 4325718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown