MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA; Intravascular Catheter

Catalog Number	386862
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that had two more incidents where the safety mechanism of these ivs did not engage, thus exposing bare needle after removal.Verbatim: i wanted to make you aware that we had two more incidents where the safety mechanism of these ivs did not engage, thus exposing bare needle after removal.Morning shift asu (xxxx inserted) 20 ga 1.00in ref# 386862, lot# 6037534.(i have the iv needle in my office and packaging).Afternoon shift asu (xxxx rn inserted) 20 ga 1.00in ref #386862, lot # 6042821, (iv needle discarded and i do not have packaging).\tno patient or team member incidents reported related to exposed needle.
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 ; +1(847)393-5694
• MDR Report Key: 50884806
• Report Number: 8041187-2026-00167
• Device Sequence Number: 21272802
• Product Code: FOZ
• UDI-Device Identifier: 00382903868629
• UDI-Public: (01)00382903868629(17)290131(10)6037534
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 386862
• Device Lot Number: 6042821
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown