MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 22GX2.00IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386814
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
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 22gx2.00in winged bc adapter / connector was defective / damaged.What happened/could have happened? we discover that the three-way tap has broken and that something is stuck in the pvk.The pvk has been set by the anaesthetist, so we are a little unsure of what it should look like.3 way valve is broken and something got stuck in the pivc when did the incident occur - during use.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and sample submitted for evaluation.The reported issue of adapter/connector defective/ damage was not confirmed upon inspection of the sample.Analysis of the sample showed the actuator was detached.No damage was observed on the catheter adapter or actuator.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 root cause could not be determined as the defect was not replicated.

• Brand Name: BD CATHENA 22GX2.00IN 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: 22346378
• Report Number: 2243072-2025-00804
• Device Sequence Number: 11961822
• Product Code: FOZ
• UDI-Device Identifier: 00382903868148
• UDI-Public: (01)00382903868148
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 08/08/2025

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: 386814
• 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: 06/08/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/11/2025
• 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