MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problems Material Frayed (1262); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during procedure, the hemodialysis catheter had failures - bleeding at the application site, breakage of the guidewire and improper blood flow.It was said that the use of the product followed the manufacturer's instructions and there were no product changes.There was no reported patient outcome.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11877844
• MDR Text Key: 252886872
• Report Number: 3009211636-2021-00118
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Device Lot Number: 0080920
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1