MAUDE Adverse Event Report: BECTON DICKINSON CATHENA; INTRAVASCULAR CATHETER

Catalog Number	386863
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/14/2025
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 us cathena 20gx1.25in straight bc safety mechanism failed.It was reported by the customer that able to disengage the safety while starting the iv.When he adds immense pressure to the catheter hub, the safety makes an audible click sound, and the safety is deactivated.When he threads the catheter the gray safety mechanism stays inside the clear cannula.When he pulls back on the needle upon threading, the needle is exposed.Verbatim: nurse was able to disengage the safety while starting the iv.When he adds immense pressure to the catheter hub, the safety makes an audible click sound, and the safety is deactivated.When he threads the catheter the gray safety mechanism stays inside the clear cannula.When he pulls back on the needle upon threading, the needle is exposed.Additional info received on 30-dec: lot # 5081570, lot # 5096085.One nurse was injured from a needle stick after placing an iv.They believed that the safety had activated but when they went to put throw away the sharp they were poked.A nurse on a different floor placed an iv and stated that the safety did not engage, they noticed the issue and no injury occurred.
Additional Manufacturer Narrative
Our quality engineer inspected the videos submitted for evaluation.The reported issues of safety mechanism failure and threading difficult were not confirmed upon inspection of the videos.From video analysis it was observed that the user applied manual force to the safety mechanism, instead of allowing the passive safety feature to engage automatically.The user held the needle hub with significant force and manually bent the needle, which placed abnormal stress on the mechanism.This resulted in mechanical malfunction and potential exposure to sharp components.It is therefore recommended to follow the instructions for use (ifu) accordingly to remove the catheter unit from needle safety shield after insertion to prevent needle retraction/safety activation failure.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: CATHENA
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23974666
• Report Number: 2243072-2026-00004
• Device Sequence Number: 4786524
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: (01)00382903868032
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 386863
• Device Lot Number: 5081570
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/21/2026
• 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