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

Model Number	8888145251
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
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, during connection process, at the time of washing/flushing the venous lumen, a "projectile"-type blood leak was observed in a small amount, a fracture in the venous lumen was noted.The physician was informed who generated an order to change the catheter.The patient could not be connected.The catheter was not repaired and there was no luer adapter issue.There was no reported patient injury.
Event or Problem Description
According to the reporter, during connection process, at the time of washing/flushing the venous lumen, a "projectile"-type blood leak was observed in a small amount, a fracture in the venous lumen was noted.The physician was informed who generated an order to change the catheter and catheter was replaced the same day the event was reported.The patient could not be connected and the treatment was suspended.Chlorhexidine gluconate 2% was the cleaning agent used.There was blood loss of less than 150ml and no transfusion was required.The catheter was not repaired and there was no luer adapter issue.Treatment was scheduled the next day and was completed.There was no reported 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
• MDR Report Key: 10339713
• Report Number: 3009211636-2020-00168
• Device Sequence Number: 3458745
• Product Code: MSD
• UDI-Device Identifier: 20884521014227
• UDI-Public: 20884521014227
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 06/30/2018
• Device Model Number: 8888145251
• Device Catalogue Number: 8888145251
• Device Lot Number: 314308X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1