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

Model Number	8888145251
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the removal of the dressing which secure the catheter before connecting to the dialysis, the device's venous luer lock adapter was damaged.The catheter's extension tube was repaired with another manufacturer's product as the intervention/treatment required for the leakage.The treatment was proceeded and completed.There was no blood loss and blood transfusion was not required.Nothing unusual was observed on the device prior to use, there was no other product utilized with the device, there was no medical intervention done to the patient, octanisept was used as the cleaning agent to clean the adapter and the cleaning agent was allowed to dry thoroughly prior to applying the ointment to the area.There was a leak and crack at the venous (blue) luer adapter.There was no instrument used to loosen or tighten the device and tego was utilized.There was no reported patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the removal of the dressing which secure the catheter before connecting to the dialysis, the device's venous luer lock adapter was damaged.The catheter's extension tube was repaired with another manufacturer's product as the intervention/treatment required for the leakage (only the discarded portion of the catheter was repaired).The treatment was proceeded and completed.There was no blood loss and blood transfusion was not required.Nothing unusual was observed on the device prior to use, there was no other product utilized with the device, there was no medical intervention done to the patient, octanisept was used as the cleaning agent to clean the adapter and the cleaning agent was allowed to dry thoroughly prior to applying the ointment to the area.There was a leak and crack at the venous (blue) luer adapter.There was no instrument used to loosen or tighten the device and tego was utilized.There was no reported patient injury.

• 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 13117868
• Report Number: 3009211636-2021-00382
• Device Sequence Number: 11902766
• 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,Followup
• Report Date (Section B): 01/18/2022

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: 12/15/2021
• Supplement Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 01/18/2022
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 60 KG