MAUDE Adverse Event Report: BECTON DICKINSON INSYTE; INTRAVASCULAR CATHETER

Catalog Number	381212
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
The secae fixator is not supposed to have any fixation with respect to the catheter.During use it was reported that, recently supplied venous cannulation catheters have been found to have a defect that compromises the safety of the procedure.A defect that compromises the safety of the procedure.The clamp does not remain firmly during cannulation, causing the catheter to detach unexpectedly from the catheter.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.

• Brand Name: INSYTE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24688544
• Report Number: 2243072-2026-00233
• Device Sequence Number: 13188242
• Product Code: FOZ
• UDI-Device Identifier: 00382903812127
• UDI-Public: (01)00382903812127(11)251015(17)300930(10)5286861
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/31/2026

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: 5286861
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown