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

Catalog Number	386865
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd us cathena 18gx1.25in straight bc leaked it was reported by the customer that product leakage through the septum.Verbatim: rcc received a complaint via email.Email(s) attached.On 4/21/25 bd issued a medical device product removal to address the reported issue of product leakage through the septum.This notification affected presource raw material inventory and/or finished goods.As a result, a supplier corrective action request is being issued for root cause investigation and corrective/preventive action.
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
No samples or photos were returned for investigation.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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22304495
• Report Number: 2243072-2025-00776
• Device Sequence Number: 4437380
• Product Code: FOZ
• UDI-Device Identifier: 00382903868650
• UDI-Public: (01)00382903868650(11)240716(17)270630(10)4198480
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/22/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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