MAUDE Adverse Event Report: BECTON DICKINSON BD US CATHENA 20GX1.00IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386883
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd us cathena 20gx1.00in winged bc had foreign matter the following information was provided by the initial reporter: it was reported by customer that safety did not deploy correctly.Verbatim: safety did not deploy correctly.Customer response received on (b)(6)2025.We did not have any negative outcome however the potential for one of the nurses to get a needle stick because the needle did not retract is still significant.This occurred multiple times with the 22g and 20g.I sent (b)(6) the picture last week.Customer response received on (b)(6)2025.1.Please share the material & lot number associated with 20g 4178006.2.Can you please provide an exact date of event for 20g? 3.If possible, can you please provide the total number of occurrences for both 22g and 22g.4.Could you please confirm if there are any samples available for 20g and 22g cathena? if so, kindly send the samples using the new shipping label.The issue is that you don't know that there is a piece of plastic on the needle until you open it.

• Brand Name: BD US CATHENA 20GX1.00IN 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: 21654415
• Report Number: 2243072-2025-00337
• Device Sequence Number: 7498903
• Product Code: FOZ
• UDI-Device Identifier: 00382903868834
• UDI-Public: (01)00382903868834(11)240702(17)270630(10)4178006
• 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): 04/25/2025

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: 386883
• Device Lot Number: 4178006
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown