MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 20GX1.25IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386811
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
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
It was reported that bd cathena 20gx1.25in winged bc safety shield activation failed safety mechanism: the canula was not protected when the catheter was removed the canula was not encapsulated after removal of the catheter - see photos when did the incident occur? - during use we've had a few problems with catheters at the clinic, particularly in the operating theatre.According to the nurses, the catheters sometimes don't go into ¿protection mode¿ and are very difficult to place.The operating theatre nurse sent me the attached photos for reference and batch information.Have you had any other complaints about this batch? after re-discussion with the operating room team, they have decided for the moment to keep this lot (because this lot is the majority in our stock).As this only concerned a few isolated cases and the equipment that seemed defective was not kept, the operating room continues with these catheters and the head nurse of the department will resensitize her staff to keep the equipment if a future incident occurs.I will of course keep you informed if we have any new information.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of safety shield activation failure was confirmed upon inspection of the photos.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.A root cause could not be established for the defect.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of safety shield activation failure was confirmed upon inspection of the photos.However, bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD CATHENA 20GX1.25IN WINGED BC
• 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: 22150888
• Report Number: 2243072-2025-00715
• Device Sequence Number: 7638682
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: (01)00382903868117(11)241102(17)271031(10)4304887
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K220584
• 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,Followup
• Report Date (Section B): 06/20/2025

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: 386811
• Device Lot Number: 4304887
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 06/20/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/19/2025; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown