MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE-N AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number	38181114
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
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
It was reported that bd insyte-n autoguard needle pierced the catheter.The following information was provided by the initial reporter: description of the occurrence (describe the deviation observed, details, and outcome of the case); the needle came out of the catheter.Date of identification of the occurrence; on (b)(6) 2025.Quantity identified with deviation; 01.When was the occurrence with the product identified (before starting the procedure, during product handling by the professional/user, during use on the patient, or after use on the patient)? during handling.Was there any harm to the patient, healthcare professional, user, or others? (provide details)? no.Was medical and/or surgical intervention necessary due to the occurrence (imaging tests, surgery, administration of medication, etc.)? (provide details)? no.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint that the catheter was punctured by the needle was confirmed and the cause appeared to be associated with use.One photograph was provided for investigation.The photo showed a 24g insyte-n autoguard iv catheter with evidence of use.The needle was protruding through the iv catheter tubing and the section of tubing between the catheter tip and needle puncture site contained what appeared to be blood residue, which suggested that the catheter tubing was punctured after the vessel was accessed.The instructions for use (ifu) warn that if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• Brand Name: BD INSYTE-N AUTOGUARD
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; 273 francisco bernardino; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22140356
• Report Number: 9610048-2025-00073
• Device Sequence Number: 20671597
• Product Code: FOZ
• UDI-Device Identifier: 00382903818112
• UDI-Public: (01)00382903818112(11)240813(17)261130(10)4211328
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 38181114
• Device Lot Number: 4211328
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown