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 Consequences Or Impact To Patient (2199)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, intraoperatively, the catheters presented numerous problems; puncture due to the guide wire, catheter bending resulting in flow issues.There was no reported patient injury.

Manufacturer Narrative

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

Event Description

According to the reporter, intraoperatively, the catheters was not giving proper flow, also the catheter had a "fold" at the time of implantation.A second catheter was used but had the same issue.A new one was used to resolve the issue.There was no reported patient injury.

• 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
• MDR Report Key: 8120019
• MDR Text Key: 128911654
• Report Number: 3009211636-2018-00378
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004801
• UDI-Public: 10884521004801
• Combination Product (y/n): N
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

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 Operator: Health Professional
• Device Expiration Date: 04/13/2022
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 1712400038
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1