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

Catalog Number	38182314
Medical Device Problem Codes	Retraction Problem (1536); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle pierced the catheter.A date range is provided, therefore the event date is not known.What deviation did you find with the material? the product is triggering before it is used.What part/component/part of the product is involved in the complaint? the safety valve was already triggered and the needle was already retracted into the disposal product.Purpose of use: in which procedure was the material being or would it be used? when puncturing the patient, it was found that the safety valve had already been activated.In which situation was the deviation identified? during use on the patient/contact with the patient.Was there any damage to the health of the patient or the professional who handled the material? no.Was medical intervention necessary? no.Was surgical intervention necessary? no.Was there a need for hospitalization or prolonged hospitalization? no.Was there any exposure to chemical/biological agents (regardless of the use of ppe)? no.Was there an accidental needle puncture? no.Did the event lead to death? no.Was anvisa notified? inform number.No.Was a second material and/or incident notified? no.Additional information received on 24-apr-2026.Email follow up: in response to your request for information regarding the incidents reported with the product units, please find the relevant details below: 1.Dates and findings of the incidents: the irregularities were identified upon opening the packaging and during the attempt to puncture the patients, within the specified timeframe.The defect was diagnosed as detailed below: units already activated/punctured: identified immediately after opening the sterile packaging.Units with mechanical failure: identified at the time of use, due to the safety device jamming.2.Use in patients: we confirm that the units were intended for different patients.It is important to note that: 3 units experienced jamming of the safety lock during the procedure.Due to the inability to handle them and the risk of contamination from prolonged exposure or device failure, the catheters were immediately discarded, making it impossible to complete the procedure in accordance with the clinical protocol.3.Photographic evidence and description of the defect: attached are photographs of the 6 packages mentioned, which show the following problems: we remain available for any other technical details or additional procedures necessary to resolve this case.02 units: safety device previously activated inside the package.1 unit: needle silicone punctured (loss of component integrity).3 units: safety lock jammed/locked, preventing proper operation and resulting in disposal to avoid contamination.
Additional Manufacturer Narrative
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.

• 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: 25083231
• Report Number: 9610048-2026-00062
• Device Sequence Number: 18783020
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 5244224
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown