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

Model Number	8888145251
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, after 48 days of catheter insertion, during normal work or hd (hemodialysis) procedure, there was a leak at the blue (venous) luer adapter where a crack/break observed.The catheter was not removed from the patient.Immediately, the adapter was repaired by handmade system wherein they used some tube from other manufacturer¿s products available in the hospital on the same day of the event, the device was used successfully and the treatment was completed.Octanisept was the cleaning agent used on the device and it was the one typically utilized on the adapters.The cleaning agent was allowed to dry thoroughly prior to applying ointment to the area.No instrument used to loosen or tighten the device, they tighten the adapters by hands only which was a special procedure and no other products being utilized with the device.Prior to dialysis, nothing unusual observed and flushing was done with normal result.No excessive force used to insert in/take out bloodline from the luer adapter.There was one drop of blood lossand air bubble.The patient did not have air embolism.Blood transfusion was not required.There was no medical intervention done to the patient.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13385927
• Report Number: 3009211636-2022-00028
• Device Sequence Number: 4998859
• Product Code: MSD
• UDI-Device Identifier: 10884521014220
• UDI-Public: 10884521014220
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2022

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: 08/10/2025
• Device Model Number: 8888145251
• Device Catalogue Number: 8888145251
• Device Lot Number: 2023300104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 01/28/2022
• Date Device Manufactured: 10/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 40 KG