MAUDE Adverse Event Report: BECTON DICKINSON BD US CATHENA 22GX2.00IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386882
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd us cathena 22gx2.00in winged bc safety mechanism failed.It was reported by customer that the needle safety feature failed, and needle tip is exposed upon removal.Also stated that the wings are not sturdy.Verbatim: needle safety feature failed; needle tip exposed upon removal.None, no injury.Discarded needle insharps container.This was a 22 gauge 2¿ cathena and inserted with ultrasound.Clinician stated the wings are not sturdy and would prefer the device without wings.
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 safety mechanism 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.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.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.
Event or Problem Description
Material # 386882, batch # 4096525.It was reported by customer that the needle safety feature failed, and needle tip is exposed upon removal.Also stated that the wings are not sturdy verbatim: needle safety feature failed; needle tip exposed upon removal.None, no injury.Discarded needle insharps container.This was a 22 gauge 2¿ cathena andinserted with ultrasound.Clinician statedthe wings are not sturdy and would prefer the device without wings.

• Brand Name: BD US CATHENA 22GX2.00IN WINGED 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 NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21277443
• Report Number: 2243072-2025-00032
• Device Sequence Number: 7908488
• Product Code: FOZ
• UDI-Device Identifier: 00382903868827
• UDI-Public: (01)00382903868827(11)240405(17)270331(10)4096525
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/06/2025

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: 386882
• Device Lot Number: 4096525
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown