MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN LLC. MEDTRONIC PALINDROME PRECISION CHRONIC HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Lot Number 8888145057P

Device Problems Contamination (1120); Leak/Splash (1354)

Patient Problem Drug Resistant Bacterial Infection (4553)

Event Date 07/10/2022

Event Type  Death  

Event Description

Patient admitted (b)(6) 2022.Perm hd catheter inserted (b)(6) 2022.Seal alert regarding recall of affected catheters from medtronic received 7/8/2022.Alert states that medtronic has identified potential leaking at the hub and recalls the affected devices.Patient identified to have a central line associated blood stream infection (clabsi) with date of event (b)(6) 2022.Perm hd catheter removed (b)(6) 2022 and tip sent for culture.Patient then expired (b)(6) 2022.Fda safety report id# (b)(4).

Event Description

Additional information received on 08/12/2022 for report mw511139 for procode.

• Brand Name: MEDTRONIC PALINDROME PRECISION CHRONIC HEMODIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MEDTRONIC / COVIDIEN LLC.
• MDR Report Key: 15192168
• MDR Text Key: 297608780
• Report Number: MW5111339
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521158273
• UDI-Public: 20884521158273
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 8888145057P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Hispanic