MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA; INTRAVASCULAR CATHETER

Catalog Number	386865
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a customer that the ivs where the valve failed, resulting in blood flowing onto the patient, nurse and floor.Verbatim: complaint via email.Email(s) attached.I just wanted to email and let you know we have had more ivs where the valve failed, resulting in blood flowing onto the patient, nurse and floor.This has already happened twice this week with two different nurses.One was a 20g and the other was an 18g.I recovered the 18g package.Lot number 5170365.Here is a pir for (b)(6).I do not have the affected product but do have one lot number.Both instances the valve for blood control failed.Date of occurrence: 6/3/26 386884 20 g x 1 386865 18g x 1.25 (lot number 5170365) additional information received on 12jun2026: the iv incidents did not occur on the same day.These incidents required the patient to be stuck again and caused blood exposure to the nurses.We currently have several issues with ivs leaking from the hub connected to the end of the iv even after we make sure it is secured and attached properly.This results in patients not receiving all their iv medications, requiring repeat needle sticks, and causing bodily fluid exposure.This happened just today with a third nurse, who had to remove and restart it.Pt arrived with a high heart rate and high blood pressure, which the doctor needed to keep below 160 systolic.Nurse on floor administered the medication prior to transport but due to the leaking iv, the patient did not receive the full dose.The patient then had no access until we could restart the iv, which was very dangerous given all the problems she was experiencing.".
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: CATHENA
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• 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: 25578791
• Report Number: 8041187-2026-00040
• Device Sequence Number: 13027860
• Product Code: FOZ
• UDI-Device Identifier: 00382903868650
• UDI-Public: (01)00382903868650(10)5170365
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: 5170365
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown