MAUDE Adverse Event Report: BECTON DICKINSON BD US CATHENA 18GX1.25IN STRAIGHT B; INTRAVASCULAR CATHETER

Catalog Number	386865
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.3.Franklin lakes has been listed as the manufacturer.G.1.Franklin lakes has been listed as the manufacturer.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 the bd us cathena 18gx1.25in straight bc had a blood leak out of the control plug.The following information was provided by the initial reporter: material#: 386865, batch#: 4304891.Verbatim: failed blood control valve.Blood exposure to clinician, iv taken out of patient.
Additional Manufacturer Narrative
One needle from cathena lot #4265921 was received with the needle locked in the tip shield.Blood residue was observed in the flash chamber.The cannula was slightly bent near the tip shield.The outside diameter (od) of the cannula was measured with calipers (id #3776 calibration date: 19 aug 2024, calibration due date: 31 aug 2025) and was found to be 0.0280".The end of the needle easily moved through the tip shield washer.The iv catheter was not provided for investigation.The complaint could not be confirmed at bd sandy as the condition of the returned sample does not support the complainant¿s description of the reported event.

• Brand Name: BD US CATHENA 18GX1.25IN STRAIGHT B
• 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: 22104704
• Report Number: 2243072-2025-00690
• Device Sequence Number: 8140522
• Product Code: FOZ
• UDI-Device Identifier: 00382903868650
• UDI-Public: (01)00382903868650(11)241102(17)271031(10)4304891
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/18/2025

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: 386865
• Device Lot Number: 4304891
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/19/2025
• 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