MAUDE Adverse Event Report: TYCO HEALTHCARE MAHURKAR Q PLUS 13.5FR X 1.5 CMCE KIT; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888135132

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

The customer reported 1 unit of 8888135132 lot 31637 that during a procedure was introduce through right jugular and, when was extract the metallic guide, resistance was evidenced then the catheter got damaged and missing tip was evidenced, a thorax rx was needed to locate the missing part to be extracted in a medical procedure.Patient involved.No sample available.Patient injury reported: yes.Medical intervention required: yes.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MAHURKAR Q PLUS 13.5FR X 1.5 CMCE KIT
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): TYCO HEALTHCARE
• MDR Report Key: 17525335
• MDR Text Key: 321065589
• Report Number: MW5132276
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 8888135132
• Device Lot Number: 031637
• Patient Sequence Number: 1