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

Model Number	8888345611
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
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 the commencement of dialysis with the newly inserted catheter, blood was found oozing out from a tiny hole at the blue port.It was stated that the leak was found at the exit site.Saline was the cleaning agent used on the device.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted no abnormalities.Pmv performed functional testing which included submerging the catheter into a water bath.The end was clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present.Both extensions were tested with acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the commencement of dialysis with the newly inserted catheter, the staff noted that there was blood leaking from a tiny hole at the blue lumen 5 minutes after the dialysis was started.It was stated that only around 5-10mls of blood was lost.The lumen were tightened by hand and saline was the cleaning agent used on the device.The blood flow rate at the time of the event was 180ml/hr and the treatment was not completed.The catheter was removed and replaced.There was no patient injury.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7620214
• Report Number: 3009211636-2018-00207
• Device Sequence Number: 1695237
• Product Code: NIE
• UDI-Device Identifier: 10884521006782
• UDI-Public: 10884521006782
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K020089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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: 03/16/2022
• Device Model Number: 8888345611
• Device Catalogue Number: 8888345611
• Device Lot Number: 1710100092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1