MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 20GX2.00IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386812
Medical Device Problem Codes	Retraction Problem (1536); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd cathena 20gx2.00in winged bc safety shield activation failed (catheter).I would like to leave you a complaint about cathena (attachment).The safety mechanism did not activate and got stuck at the base of the needle.Therefore, the needle was hazardous.This has happened before as well (previous complaint number (b)(4) ).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From the returned photo, observed that the safety mechanism was not activated.However, unable to evaluate from the photo whether there is safety activation component failure/damage that resulted in the safety activation failure as the actual sample was not returned.As current control, there are outgoing functional test and in-process functional test to check and detect safety activation failure.
Event or Problem Description
I would like to leave you a complaint about cathena (attachment).The safety mechanism did not activate and got stuck at the base of the needle.Therefore, the needle was hazardous.This has happened before as well (previous complaint number (b)(4)).
Event or Problem Description
I would like to leave you a complaint about cathena.The safety mechanism did not activate and got stuck at the base of the needle.Therefore, the needle was hazardous.This has happened before as well (previous complaint number (b)(4)).

• Brand Name: BD CATHENA 20GX2.00IN 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: 19744729
• Report Number: 2243072-2024-00798
• Device Sequence Number: 9144630
• Product Code: FOZ
• UDI-Device Identifier: 00382903868124
• UDI-Public: (01)00382903868124
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2024

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: 09/30/2024
• Device Catalogue Number: 386812
• Device Lot Number: 1274248
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 08/06/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/06/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown