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

Catalog Number	38183414
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr opened based on additional sample received and confirmation from the rep that it was related to the same type of issue.B3.The date received by manufacturer has been used for this field.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
Additional sample received requiring a new report.It was reported that the needle does not retract.Originally reported issue of "when the safety button is activated, the needle does not retract into the retraction chamber".
Additional Manufacturer Narrative
Correction: based on investigation findings, the as analyzed failure is not a reportable malfunction.Cancel mdr.Device evaluation: a device history record review was completed for provided material number 38183414 and lot number 5213614.The review did not reveal any abnormalities detected during the production process that could have contributed to the reported defect, and all quality tests were found to be within specification.To aid in the investigation of this issue, the affected physical sample was received for evaluation by our quality team.Through examination of the sample, the catheter/adapter component was lodged in the needle shield component.The needle was fully retracted.Only the issue of catheter/adapter stuck in shield was observed with the sample returned for this report.Based on the investigation conducted to date, a possible cause for the defect is excessive compression applied during the assembly of the shield onto the grip, which may allow the catheter to pass beyond the internal retention tab and remain trapped inside the needle cover.Corrective actions related to the catheter release premature defect are being investigated.Containment actions implemented include adjustment of the lower stopper position at the assembly station, with the objective of controlling the downward travel and insertion force of the shield, preventing the excessive compression observed.Another containment action implemented was adjustment of the sensor paddles at the shield placement station to ensure improved positioning and detection of the assembly.
Event or Problem Description
No additional information from customer.

• 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: 24324844
• Report Number: 9610048-2026-00021
• Device Sequence Number: 15871737
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: (01)00382903818341
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 38183414
• Device Lot Number: 5213614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown