MAUDE Adverse Event Report: BECTON DICKINSON CATHENA; INTRAVASCULAR CATHETER

Catalog Number	386805
Medical Device Problem Codes	Activation Failure (3270); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 20gx2.00in straight bc safety mechanism failed inserting pivc and during insertion the needle safety mechanism did not work, leaving the needle exposed.Cannula stayed in patient.Customer kept the needle and is able to send.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issue of catheter defective/damaged was confirmed upon inspection of the sample.Analysis of the sample showed no damage to the tip shield assembly.The returned sample had difficult activation and found scratches on the needle surface.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.The assembly process was reviewed.And found the dent on the cannula could possibly be caused by the cannula insertion gripper, as the position of the gripper matches the dent mark location.The washer was inspected and no abnormalities were observed.The possible root cause for the scratch on the cannula is the insertion gripper moving against the cannula during insertion to the needle hub/tip shield and washer subassembly.

• Brand Name: CATHENA
• 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: 22521527
• Report Number: 2243072-2025-00878
• Device Sequence Number: 20847747
• Product Code: FOZ
• UDI-Device Identifier: 00382903868056
• UDI-Public: (01)00382903868056(11)240505(17)270430(10)4116854
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 386805
• Device Lot Number: 4116854
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown