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

Model Number	8888222220
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one video of a device.The video depicts the catheter being used with a syringe in a kidney shaped bowl full of clear fluids.The catheter is screwed to the red and blue lumen, the plunger is pulled back to draw fluids and then pressed to push the fluids through the catheter.Red fluid is then added to the bowl and the same process is repeated.Records from each manufacturing lot are thoroughly reviewed to ensure that products are 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, the catheter's red line (arterial) was difficult to flush/aspirate than that of the blue line (venous), wherein the arterial line was not patent/not flowing smoothly.It was stated that the catheter was repaired, there was no luer adapter issue and the cleaning agent used was sodium chloride.The insertion site was treated prior to product placement.There was no patient involvement.
Event or Problem Description
According to the reporter, the catheter's red line (arterial) was difficult to flush/aspirate than that of the blue line (venous), wherein the arterial line was not patent/not flowing smoothly.It was stated that the catheter was repaired, there was no luer adapter issue and the cleaning agent used was sodium chloride.The insertion site was treated prior to product placement.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one video.The video depicts the catheter being used with a syringe in a kidney shaped bowl full of clear fluids.The catheter is screwed to the red and blue lumen, the plunger is pulled back to draw fluids and then pressed to push the fluids through the catheter.Red fluid is then added to the bowl and the same process is repeated.Post market vigilance (pmv) led an evaluation of four mahurkar elite acute dual lumen catheter kits.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR ELITE
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8476185
• Report Number: 3009211636-2019-00073
• Device Sequence Number: 19239704
• Product Code: MPB
• UDI-Device Identifier: 10884521125841
• UDI-Public: 10884521125841
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K120674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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: 03/02/2023
• Device Model Number: 8888222220
• Device Catalogue Number: 8888222220
• Device Lot Number: 1808500097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1