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

Model Number	8888345629
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post- operatively, there was a low flow performance and catheter obstruction or no flow at the lumen.Flushing was performed prior to insertion obtaining a below-expected results.It was stated that they tried to invert the lines but to no avail and they couldn't perform the wash with the syringe.It was also stated that an heparin was used as anti-coagulant.The dialysis was not performed due to lack of catheter flow.It was reported that there was no permanent injury to the patient and the patient was okay.
Additional Manufacturer Narrative
Please note that the fdd for this product is only inclusive of fdd (b)(4) and the previous fdd (b)(4) is not applicable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post- operatively, the catheter's lumen had a low or no flow issue.Flushing was performed prior to insertion obtaining a below-expected results.It was stated that they tried to invert the lines but to no avail and they couldn't perform the wash with the syringe.It was also stated that an heparin was used as anti-coagulant.The dialysis was not performed due to lack of catheter flow and there was a need for a catheter replacement.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: 7842264
• Report Number: 3009211636-2018-00298
• Device Sequence Number: 1271636
• Product Code: NIE
• UDI-Device Identifier: 10884521006799
• UDI-Public: 10884521006799
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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 Model Number: 8888345629
• Device Catalogue Number: 8888345629
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other