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

Catalog Number	386865
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
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 18gx1.25in straight bc blood leaks out of control plug it was reported by customer that the cathena blood control not working.Allowing for blood return upon placing iv catheter.Verbatim: cathena blood control not working.Allowing for blood return upon placing iv catheter bd rep response on (b)(6) 2025 for (b)(4): 1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.2.In (b)(4), the lot number was mentioned as 4124016, but the attached product image shows the lot number as 4198480.Could you please confirm which lot is experiencing the reported issue, or if both are affected? both lot numbers are affected.Customer response on (b)(6) 2025.For (b)(4): 1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Due to a manufacturing defect, there is potential for a hole in the septum of the cathena 18- and 20-gauge catheters.The hole may result in blood leakage from the septum during insertion.The blood leakage may cause blood exposure or the need for a second iv to be placed.The replacement of the iv may result in a brief delay in therapy which would not be expected to result in an adverse event.Bd has identified root cause and initiated corrective actions to prevent recurrence of this issue.

• Brand Name: BD US CATHENA 18GX1.25IN STRAIGHT 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: 21858935
• Report Number: 2243072-2025-00529
• Device Sequence Number: 20010895
• Product Code: FOZ
• UDI-Device Identifier: 00382903868650
• UDI-Public: (01)00382903868650(11)240505(17)270430(10)4124016
• 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): 05/20/2025

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: 4198480
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown