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

Catalog Number	381212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Clinician removed the cannula after experiencing difficulty threading it into the vein at which point noted the plastic had splintered.Insertion technique was reviewed with user confirmed that they had carried out the correct technique.Patient experienced pain.A second device was used with no incident.
Additional Manufacturer Narrative
To aid in the investigation of this issue, the affected physical sample was returned for evaluation by our quality team.Through examination of the sample, no damage was observed at the catheter tip; however, a small hole in the catheter body was detected.As a lot number was unknown for this incident, a review of the production history records could not be completed.Based on the small hole presented in the catheter body, this defect has been identified as needle through catheter.This type of issue may occur during use.If the 360-degree rotation of the catheter/needle is not performed during venipuncture, slight resistance may occur when removing the needle which may cause the healthcare professional to reinsert the needle, causing the needle to pierce the catheter during the procedure.This type of defect could also occur during the assembly process if a failure in the vision system allowed a pierced catheter to pass through to the customer.However, it is important to note that if the catheter was already pierced, venipuncture would not have been possible.Without the lot number, further verification of the manufacturing process cannot be completed.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: INSYTE
• 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: 23983302
• Report Number: 9610048-2025-00201
• Device Sequence Number: 10609110
• Product Code: FOZ
• UDI-Device Identifier: 00382903812127
• UDI-Public: (01)00382903812127
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 381212
• Device Lot Number: UNKNOWN
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown