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

Model Number 8888135161

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, prior to use, it was observed that the catheter had a "hole" in it.Air leak was observed when 10ml was a spirated from each port.It was also mentioned that when a saline syringe was attached to the arterial port, leaking was noted form the small hole where the clear tubing (extension tube) attaches to the arterial port.There was no patient involvement.

• Brand Name: MAHURKAR
• 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: 9538596
• MDR Text Key: 194337800
• Report Number: 3009211636-2020-00003
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006355
• UDI-Public: 10884521006355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2024
• Device Model Number: 8888135161
• Device Catalogue Number: 8888135161
• Device Lot Number: 1904900105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/02/2020
• Date Device Manufactured: 03/08/2019
• 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