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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the material catheter no.20 used and the safety device did not function.
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.
Additional Manufacturer Narrative
Investigation results: as the batch number is unknown, it was not possible to conduct a detailed investigation into the product in question.A likely root cause may be related to spring formation in one of the zones.1_ lack of spring check station adjustments.2_ incorrect spring check challenge parts.3_ lack of check frequency at the spring check station.The following corrections were carried out for this reason: improvements to the spring forming machine were implemented in a capa in august-2024: the following checks were included in the weekly preventive check: assessment of the cutting tool (knife) and replacement if necessary.Evaluate by checking if the cut has burrs: if it has burrs (bad cut) and if it has no burrs (good cut).Describe in the note whether the knife is good or bad and whether or not the replacement was carried out and assessment of the mandrel and replacement if necessary.Evaluate by checking if the cut has burrs: if it has burrs (bad cut) and if it has no burrs (good cut).Describe in the note whether the mandrel is good or bad, whether or not the replacement was carried out.A probable root cause may also be related to damage to the cylinder, possibly caused by pressure variation or a failure in the sensor reading at the barrel positioning station.This damage may result in the needle not being fully activated.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 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: 23376310
• Report Number: 9610048-2025-00154
• Device Sequence Number: 21048678
• 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,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: UNKNOWN
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown