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

Model Number 251285-40E

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2019

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): PAJUNK MEDICAL SYSTEMS; 6611 bay circle, suite 140; norcross GA 30071
• MDR Report Key: 8324911
• MDR Text Key: 135709072
• Report Number: 8324911
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 04048223027387
• UDI-Public: (01)04048223027387(11)181113(17)231112(10)1277
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

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