MAUDE Adverse Event Report: PAJUNK MEDICAL SYSTEMS E-CATH ACC. TSUI; CATHETER, CONDUCTION, ANESTHETIC

Model Number	251285-40E
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Sterile catheter kits missing the tubing that connects on the luer lock part on the needle (not the tubing attached to the inner catheter).

• Brand Name: E-CATH ACC. TSUI
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): PAJUNK MEDICAL SYSTEMS; 6611 bay circle, suite 140; norcross GA 30071
• MDR Report Key: 8324911
• Report Number: 8324911
• Device Sequence Number: 18877790
• Product Code: BSO
• UDI-Device Identifier: 04048223027387
• UDI-Public: (01)04048223027387(11)181113(17)231112(10)1277
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/04/2019
• Report Date (Section F): 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 251285-40E
• Device Catalogue Number: 251285-40E
• Device Lot Number: 1277
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/04/2019