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

Model Number	8813793013
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to insertion, when they tried to pass the guide wire through the lumen, it was found that the arterial lumen was "covered" and did not allow the guide wire to pass.It was reported that the device was flushed with saline prior to use.The saline passed through the lumen but the nurse felt that the lumen was a little occluded.Nothing unusual was observed on the guide wire and the guide wire that was used was the one that came from the kit and there was no problem with the catheters dimension and it matched the dimension printed on the label.It was stated that the catheter was not repaired, there was no leak, there was no luer adapter issue.There was no reported patient involvement.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• MDR Report Key: 9887168
• Report Number: 3009211636-2020-00074
• Device Sequence Number: 11367774
• Product Code: FOZ
• UDI-Device Identifier: 10884521004832
• UDI-Public: 10884521004832
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K943349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2023
• Device Model Number: 8813793013
• Device Catalogue Number: 8813793013
• Device Lot Number: 1805800139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1