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

Catalog Number	38183314
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/18/2025
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.E1.All demographic information on the regulatory document states "confidential".
Event or Problem Description
It was reported that a 20g venous catheter malfunctioned, opening in the patient's vein and failing to activate the safety device.
Additional Manufacturer Narrative
Additional information: (e) initial reporter details.Investigation results: in addition to the fact that no records were found during the analysis of the batch history and non-compliance records, there is no evidence that could lead to this complaint, we did not receive samples/photos to analyze this complaint, and it is not possible to confirm this complaint.Based on the results of the investigation, to date a root cause has not been determined for this complaint.A probable root cause may also be related to damage to the cylinder, caused by a possible pressure variation or a failure in the sensor reading at station 5.52.4 (barrel positioning station).This damage may lead to incomplete needle activation and/or may be associated with a failure in the uv adhesive application process, resulting in the adhesive being applied on the button instead of on the component hub.However, for a detailed analysis, the presence of the physical sample would be necessary.The defects will be monitored during quality trend analysis (qda) meetings.
Event or Problem Description
No additional information.

• Brand Name: INSYTE 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 IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23799443
• Report Number: 9610048-2025-00183
• Device Sequence Number: 5093371
• Product Code: FOZ
• UDI-Device Identifier: 00382903818334
• UDI-Public: (01)00382903818334
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 38183314
• Device Lot Number: 5066394
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 12/14/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown