MAUDE Adverse Event Report: COVIDIEN LP PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED, COATED

Model Number 8888123405P

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2022

Event Type  malfunction  

Event Description

The stylet would not advance through the lumen during prep.The catheter was replaced.There was no harm to the patient.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13450743
• MDR Text Key: 285045786
• Report Number: 13450743
• Device Sequence Number: 1
• Product Code: NYU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2022

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
• Device Model Number: 8888123405P
• Device Catalogue Number: 8888123405P
• Device Lot Number: 2115800062
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other