MAUDE Adverse Event Report: BD SUZHOU (MDS) BD CATHENA 22GX1.00IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386813
Medical Device Problem Codes	Break (1069); Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd cathena 22gx1.00in 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
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of adapter/connector defective/damaged 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.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issue of adapter/ connector defective/ damaged was not confirmed upon inspection of the sample.Analysis of the sample showed no damage or defects on the actuator or adapter.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Upon inspection of the returned sample, the actuator was found detached and the spring was missing.Currently, a vision system is in place to verify the presence and positioning of the spring and actuator, as well as to check the septum spring and actuator.However, the defect described in the event could not be replicated during testing.The root cause could not be determined.

• Brand Name: BD CATHENA 22GX1.00IN WINGED BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• 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: 22346381
• Report Number: 2243072-2025-00803
• Device Sequence Number: 4799084
• Product Code: FOZ
• UDI-Device Identifier: 00382903868131
• UDI-Public: (01)00382903868131(10)386814
• 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,Followup
• Report Date (Section B): 08/28/2025

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: 386813
• 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; 08/28/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/13/2025; 08/28/2025
• 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