MAUDE Adverse Event Report: NIPPON COVIDIEN LIMITED ULTRAFLO; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888221220

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the catheter was inserted from left internal jugular vein and dialysis was performed, but it was stated that recirculation was occurred and the catheter was removed.Insufficient flow was observed and the catheter was found to bent.The catheter was not replace and the graph was able to used, so a puncture was made from the graph for treatment.There was no reported patient injury.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found that the catheter cannula was bent.Both luer adapters, clamps, extension tubes, hub, and suture wing appeared intact.Functional testing noted that the catheter was submerged into a water bath and the ends were clamped.A syringe was used to inject air to observe leakage and no air bubbles were present.Both extensions were tested with acceptable results.It was reported that there was an insufficient flow issue.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ULTRAFLO
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): NIPPON COVIDIEN LIMITED; 1217-1 tomonaga, fukuro; fukuroi 437-0 004
• MDR Report Key: 10324176
• MDR Text Key: 200424652
• Report Number: 3009211636-2020-00148
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521125735
• UDI-Public: 10884521125735
• Combination Product (y/n): N
• PMA/PMN Number: K120674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888221220
• Device Catalogue Number: 8888221220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1