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

Model Number 8888135191

Device Problems Device Markings/Labelling Problem (2911); Infusion or Flow Problem (2964)

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

Event Date 09/09/2021

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 label of the catheter branches indicated heparinization with 1.3 ml for a 19.5 cm catheter, while the same code with another batch indicated 1.6ml heparinization (prime volume).During the device follow-up (right after the catheter insertion/installation), the catheter did not allow the patient to be dialyzed and it was indicated that it gave a flow of 100 ml and collapsed - meaning it did not give the required flows since it created resistance but the catheter had no rupture, undamaged and did not broke.The volumes were also confirmed after the catheter was installed - when it was trying to dialyzed.It was also said that after that installation procedure, fluoroscopic visualization was done for location confirmation and the catheter was visualized shorter than usual.Nothing unusual observed prior to use.No damage noted on the device packaging.The box that the device came in and the sterile barrier were intact.The catheter was not repaired and had no leak.There was no connector issue.Clorhexidina 2% was the cleaning agent used on the device.Tego was not utilized.The insertion site was treated with suero fisiologico prior to product placement.No other products being utilized with the device.There was no blood loss and no blood transfusion was required.There were no patient symptoms or complications associated with this event.The event did not lead to or extend patient hospitalization.Catheter removal was done on the same date of the event, however, there was no replacement of the catheter and that the management of the patient was pharmacological.There was no reported patient injury.

Manufacturer Narrative

Additional info: b5, g3 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.

Event Description

According to the reporter, the label of the catheter branches indicated heparinization with 1.3 ml for a 19.5 cm catheter, while the same code with another batch indicated 1.6ml heparinization (prime volume).During the device follow-up (right after the catheter insertion/installation), the catheter did not allow the patient to be dialyzed and it was indicated that it gave a flow of 100 ml and collapsed - meaning it did not give the required flows since it created resistance but the catheter had no rupture, undamaged and did not broke.The volumes were also confirmed after the catheter was installed - when it was trying to dialyzed.It was also said that after that installation procedure, fluoroscopic visualization was done for location confirmation and the catheter was visualized shorter than usual.Nothing unusual observed prior to use.No damage noted on the device packaging.The box that the device came inand the sterile barrier were intact.The catheter was not repaired and had no leak.There was no connector issue.Clorhexidina 2% was the cleaning agent used on the device.Tego was not utilized.The insertion site was treated with suero fisiologico prior to product placement.No other products being utilized with the device.There was no blood loss and no blood transfusion was required.There were no patient symptoms or complications associated with this event.The event did not lead to or extend patient hospitalization.Catheter removal was done on the same date of the event, however, there was no replacement of the catheter done.The patient had noinstallation of a new catheter as it was decided not to dialyze and decided through medications to handle the problem with a favorable response from the patient.There was no reported patient injury.

Manufacturer Narrative

Additional information: a5a, a5b, d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was an insufficient flow issue and there was an issue with the labelling.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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: 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12590563
• MDR Text Key: 275376343
• Report Number: 3009211636-2021-00280
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• 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: 2106900230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2021
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White