MAUDE Adverse Event Report: BECTON DICKINSON CATHENA; INTRAVASCULAR CATHETER

Catalog Number	386881
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that we had another cathena not safety, verbatim: we had another cathena not safety, this one was a winged version.
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
Our quality engineer inspected the photos submitted for evaluation.The reported issue safety shield activation failure was confirmed upon inspection of the photos.The probable root cause is attributed to improper user handling.The adapter was not firmly seated on the tip shield in accordance with the instructions for use (ifu).If there is a gap between the adapter and tip shield interface, it causes the v-clip to not hold the adapter properly, potentially resulting in device malfunction and the needle being exposed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: CATHENA
• 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: 25045756
• Report Number: 2243072-2026-00321
• Device Sequence Number: 15866268
• Product Code: FOZ
• UDI-Device Identifier: 00382903868810
• UDI-Public: (01)00382903868810(17)281031(10)5329238
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/19/2026

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: 386881
• Device Lot Number: 5329238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown