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	12/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during normal use, it was observed that the blue (venous) luer adapter had a crack and leak was noted.There was no blood loss and blood transfusion was not required.The luer adapter was repaired as the intervention/treatment required for the leakage, nothing unusual was observed on the device prior to use, priming was performed with normal result, there was no other product utilized with the device, the blood of the patient was safely returned, there was no medical intervention done to the patient and the cleaning agent was allowed to dry thoroughly prior to applying the ointment to the area.The treatment was completed after the luer adapter was repaired by using the home made method (repaired the luer lock adapter using some tubes and luer lock available in the hospital), there was no instrument used to loosen or tighten the device, octanisept was used as the cleaning agent on the device and to clean the adapters.There was a luer adapter issue (broken) and there was no patient symptoms or complications associated with this event.
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: 13385896
• Report Number: 3009211636-2022-00027
• Device Sequence Number: 17312953
• 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: 51 YR
• Patient Sex: Male