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

Catalog Number	NS38182314
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 the needle did not retract.When salinizing a venous access, it was noticed that the valved connector was externalized.Additional information received on 03-mar-2026 email follow up: could you please confirm how many units of the product presented the issue/defect? three catheters showed the deviation.When was the issue/defect identified: before, during, or after use? the defect was only observed after the puncture, as the complaint also referred to the needle not being retracted.Was there any harm to the patient's health? if so, please explain in detail.We received no information about damage, but it is a risky circumstance.
Additional Manufacturer Narrative
To aid in the investigation of this issue, one (1) picture sample was received for evaluation by our quality team.Through examination of the picture, the product appeared used and the safety device was not activated.A device history record review was completed for provided material number 38182314 and lot number 5244226.The review did reveal records of activation failure which may be related to this reported incident.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.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.Corrective actions related to needle retraction failure are currently being addressed with containment actions and implementations of increased sampling and machine maintenance underway until permanent actions are implemented.
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 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: 24648003
• Report Number: 9610048-2026-00043
• Device Sequence Number: 9786355
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: (01)00382903818235
• 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): 04/21/2026

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: NS38182314
• Device Lot Number: 5244226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown