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

Catalog Number	38183414
Medical Device Problem Codes	Use of Device Problem (1670); Material Perforation (2205); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.This mdr is being filed based on an investigation finding that changed the reportability.Device evaluation: a device history record review was completed for provided material number 38183414 and lot number 5126230.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, one (1) picture sample was received for evaluation by our quality team.The photo displays the unit containing media indicating use.The adapter does not appear to be seated on the grip, it is slightly advanced and the needle is piercing through the middle of the catheter tubing.The reported complaint was confirmed.This damage may occur during manufacturing.When the adapter is loaded to the grip, it is possible that incorrect equipment settings may cause a catheter spear through.A 100% vision system inspection and quality control plan visual inspections are performed to mitigate the occurrence of this defect.Additionally, this also may occur during use if the needle is inserted at an angle or if the needle is slid up and down the catheter during insertion.Since the unit contains media, this most likely occurred during use.If this had occurred during manufacturing, the damage would have been evident before use.The instructions for use (ifu) state, "if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur." no other damage was identified from the photograph.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.Manufacturing controls are in place to mitigate the occurrence of this type of damage.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.
Event or Problem Description
The investigation findings indicate that the needle pierced the catheter.The customer reports that the catheter was bent.It was reported that we have received several complaints from the healthcare team regarding the performance of the device during venipuncture.According to the professionals, the angiocath has presented difficulty in progression, with frequent reports that the catheter ¿bends¿ during the puncture attempt.This situation ends up making venous access impossible on the first attempt, resulting in multiple punctures in the same patient.Date of identification of the occurrence; it occurred on several days.When was the occurrence with the product identified (before starting the procedure, during handling of the product by the professional/user, during use on the patient, or after use on the patient)? during use on the patient was there any harm to the patient, healthcare professional, user, or others? (provide details); in addition to discomfort and additional risk to the patient, the problem has generated significant waste of materials, since angiocaths that present this complication become unusable, directly impacting the institution's costs.Was medical and/or surgical intervention necessary due to the incident (imaging tests, surgery, administration of medication, etc.)? (provide details); no.

• 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: 25138234
• Report Number: 9610048-2026-00063
• Device Sequence Number: 13106156
• 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
• Report Date (Section B): 05/08/2026

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: 5126230
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown