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

Model Number 8888135191

Device Problems Migration or Expulsion of Device (1395); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Event Description

According to the reporter, 2 days after the catheter inserted on the femoral vein, when the dialysis treatment and flushing was not performed yet, as soon as opening the accessory material at the puncture point, it was found that the suture wing prolapsed (detached) while both of its stitches were still holding to the patient¿s skin and the catheter was out of the ring of suture wing, the catheter moved about halfway out of intended position.The catheter was immediately replaced with the same lot number on the same day of the event, the new device was used successfully/normally and the procedure was completed.No other products being utilized with the device.The ring of the suture wing was not broken and no other defects/damages found on the product aside from detachment of suture wings.Nothing happened, no unnecessary movements, and no other factors such as clothing that might contributed to the event.Nothing else unusual/no other problems observed on the device.The device was not repaired, there was no leak, and no luer adapter issue.The issue did not lead to vessel or vein damage.There was no infection at the moment.There was no blood loss and blood transfusion was not required.No medical intervention/treatment required as the result of the event.There was no patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: d9, g1 (mfr contact first name, last name, email, phone number), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the suture wing was cracked, broken, or detached from the catheter.It was reported that there was a securement wing issue and there was an ingrowth or catheter migration issue.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue can be avoided if excessive force on the connection point between the suture wing and the cannula is exercised during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: suture the catheter to the skin using rotatable suture wing.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: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13118290
• MDR Text Key: 283081607
• Report Number: 3009211636-2021-00386
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

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
• Device Operator: Health Professional
• Device Model Number: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 2104200122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male