MAUDE Adverse Event Report: BD SUZHOU (MDS) BD CATHENA 20GX1.00IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386803
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause couldn't be determined due to unavailability of sample/batch/lot number information.A complaint history record (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record (dhr) review could not be performed as no batch/lot number was made available for this reported event.A review of the applicable a-eura (b)(4) and rev# 13 indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.
Event or Problem Description
It was reported that bd cathena 20gx1.00in straight bc safety shield activation failed.While pulling the clear chamber, she felt a resistance and when she finally retracted it she felt the safety cap broke and fail to be engaged.

• Brand Name: BD CATHENA 20GX1.00IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21060533
• Report Number: 2243072-2024-01280
• Device Sequence Number: 20871280
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: (01)00382903868032
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2024

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 Catalogue Number: 386803
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown