MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888211416

Device Problem Material Frayed (1262)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the guidewire was unraveled.They were able to pull it out of the patient and perform a scan to be sure that not was left.

• Brand Name: MAHURKAR ELITE
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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: 9601119
• MDR Text Key: 175373912
• Report Number: 3009211636-2020-00018
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521126015
• UDI-Public: 10884521126015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2020
• Device Model Number: 8888211416
• Device Catalogue Number: 8888211416
• Device Lot Number: 1835100092
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2019
• Date Device Manufactured: 03/01/2019
• 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
• Patient Outcome(s): Other