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

Catalog Number	38182314
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2026
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 the mandrel collection device did not work, causing a puncture accident.On the same day, another employee identified a second unit with the same problem.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed for provided material number 38182314 and lot number 5244218.The review did reveal the detected abnormalities during the production process.Although this complaint does not include samples or photos, based on the records found in the batch histories, the quality notification, and the corrective maintenance work order, it was possible to confirm the occurrence of this complaint.Based on the investigation conducted so far, a likely cause would be a failure in the uv glue application, resulting in the adhesive being applied on the button component and the spring instead of on the component hub and another possible cause identified would be improper spring forming, resulting in a ¿burst¿ spring, in which the last coil is poorly positioned, preventing the proper downward movement of the hub.In addition corrective actions related to the needle retraction failure defect are being addressed under capa and following root causes were identified as improper handling of the glue nozzle, lack of cleaning of glue tanks and nozzles, failure during barrel-to-grip assembly, lack of preventive maintenance, external damage to the grip during assembly, and gap in preventive maintenance.A corrective and preventive action was planned to prevent the occurrence of this type of defect.As containment actions, increased sampling (until permanent actions are implemented); and machine maintenance were implemented.However, the lot reported was manufactured prior to this capa implementation was planned.If the affected samples become available for this incident or any potential future incidents, we would greatly appreciate the opportunity to review them.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• 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 INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24475630
• Report Number: 9610048-2026-00031
• Device Sequence Number: 10308641
• Product Code: FOZ
• UDI-Device Identifier: 30382903818236
• UDI-Public: (01)30382903818236
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 38182314
• Device Lot Number: 5244218
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown