MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 8813793009

Device Problems Difficult to Advance (2920); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, it was stated that the catheter had problems in the efficiency of supply of blood flow during hemodialysis.After the insertion with initial flow and with adequate care, it does not allow good flow even in the medium term, which necessitates frequent device changes.The guide wire was inadequate, necessitating opening of another device just to use the guide wire.There was no reported patient outcome.

• Brand Name: MAHURKAR
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8791115
• MDR Text Key: 151126036
• Report Number: 3009211636-2019-00165
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004801
• UDI-Public: 10884521004801
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K943349
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2022
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 1713900127
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Date Device Manufactured: 05/25/2017
• 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