MAUDE Adverse Event Report: COVIDIEN LLC MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888135191

Device Problem Material Puncture/Hole (1504)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, after catheterization, blood oozed from the junction between the venous end and the extension tube.The catheter was repaired.Routine disinfection was done to clean the device.Tego was not utilized and there was no luer adapter issue.The insertion site was not treated prior to product placement.There was no reported patient outcome.

Event Description

According to the reporter, after catheterization, blood oozed from the extension tube near the venous luer adapter.Nothing unusual was observed on the device prior to use the catheter was repaired.Normal flushing was done.Routine disinfection was done to clean the device with unspecified cleaning agent.Tego was not utilized and there was no luer adapter issue.The insertion site was not treated prior to product placement.The product was replaced with a competitor's product as a remedial action and to resolve the issue.The procedure was completed after resolving the issue.Blood transfusion was not needed.There was no intervention/medical treatment required as the result of the event.There was no reported patient injury.

Manufacturer Narrative

Additional information: b5, d3 (mfr name, street 1, mfr city, mfr region, country and postal code), d6b, d9, g3, h3, h6 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Additional information: b5, g3 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, after catheterization, blood oozed from the extension tube near the venous luer adapter.Nothing unusual was observed on the device prior to use.Normal flushing was done.Routine disinfection was done to clean the device with unspecified cleaning agent.Tego was not utilized and there was no luer adapter issue.The insertion site was not treated prior to product placement.The product was replaced with a competitor's product as a remedial action and to resolve the issue.The procedure was completed after resolving the issue.There was unspecified amount of blood loss.Blood transfusion was not needed.There was no intervention/medical treatment required as the result of the event.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.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was a leak or hole on the extension tube at or near the luer adapter.The reported issue 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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, after catheterization, blood oozed from the extension tube near the venous luer adapter.Nothing unusual was observed on the device prior to use.Normal flushing was done.Routine disinfection was done to clean the device with unspecified cleaning agent.Tego was not utilized and there was no luer adapter issue.The insertion site was not treated prior to product placement.The product was replaced with a competitor's product as a remedial action and to resolve the issue on the same day of the event.The procedure was completed after resolving the issue.There was unspecified amount of blood loss.Blood transfusion was not needed.There was no intervention/medical treatment required as the result of the event.There was no reported patient injury.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18991017
• MDR Text Key: 339007506
• Report Number: 3009211636-2024-00087
• 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: K192302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/06/2024

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: 2226500183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 05/30/2024; 06/20/2024; 08/05/2024
• Supplement Dates FDA Received: 06/04/2024; 06/21/2024; 08/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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