MAUDE Adverse Event Report: BECTON DICKINSON CATHENA; INTRAVASCULAR CATHETER

Catalog Number	386859
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd us cathena 24gx0.75in straight needle retraction failed it was reported by customer that the angiocath incident where the needle caught inside the catheter and the rn was not able to remove it.Verbatim: rcc received a complaint via email.I have cc¿d (b)(6) to report the complaints below: awareness date: 6/16/2025 we had another angiocath incident where the needle caught inside the catheter and the rn was not able to remove it, therefore causing the patient to endure another peripheral stick.#24 gauge bd cathena.Lot#2309256 ref#(b)(4).
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 photo submitted for evaluation.The reported issue of needle retraction failure was not confirmed upon inspection of the photo.Bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.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: 22395514
• Report Number: 2243072-2025-00821
• Device Sequence Number: 11987322
• Product Code: FOZ
• UDI-Device Identifier: 00382903868599
• UDI-Public: (01)00382903868599(17)251031(10)2309256
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/05/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 386859
• Device Lot Number: 2309256
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown