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

Model Number 8888135241

Device Problems Material Puncture/Hole (1504); Infusion or Flow Problem (2964)

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

Event Date 11/28/2020

Event Type  malfunction  

Event Description

According to the reporter, the patient with chronic renal insufficiency, hypervolemic cardiac insufficiency and acute pulmonary edema was indwelled with a dialysis catheter on november 27 at 15:30 and crrt (continuous renal replacement therapy) treatment was started at 16:25.On november 28 at 2:50, the dialysis catheter was not smooth because the flow was insufficient.The line was not hard to flush with the syringe.After flushing, the catheter was clamped.After adjusting the position of the pipeline, the nurse found that the arterial extension tube near the luer adapter was oozing blood when the flow stop clip was opened and ready to re-connect the machine.The examination found a crack at the arterial extension tube and they immediately disconnected the crrt machine.It was reported to the doctor who removed the dialysis catheter.The catheter was not repaired previously even before the issue occurred.Tego was not utilized and there was no luer adapter issue.The insertion site was treated with iodophor prior to product placement, it was the cleaning agent used on the device and typically utilized to clean the adapters.There was no ointment utilized.Nothing unusual was observed on the device prior to use.No other products being utilized with the device.The clamps were moved to a new location after each treatment.The product was replaced/re-inserted with a new catheter (another brand) to resolve the issue.Treatment was completed.There was a small amount of blood loss and blood transfusion was not required.There was no reported patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

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 patient with chronic renal insufficiency, hypervolemic cardiac insufficiency and acute pulmonary edema was indwelled with a dialysis catheter on (b)(6) at 15:30 and crrt (continuous renal replacement therapy) treatment was started at 16:25.On (b)(6) at 2:50, the dialysis catheter was not smooth because the flow was insufficient/partial flow but not completely occluded or blocked.(it was found not long after the catheter was connected to the crrt machine).The line was not hard to flush with the syringe.After flushing, the catheter was clamped.After adjusting the position of the pipeline, the nurse found that the arterial extension tube near the luer adapter was oozing blood when the flow stop clip was opened and ready to re-connect the machine.The examination found a crack at the arterial extension tube and they immediately disconnected the crrt machine.It was reported to the doctor who removed the dialysis catheter.The catheter was not repaired previously even before the issue occurred.Teg o was not utilized and there was no luer adapter issue.The insertion site was treated with iodophor prior to product placement, it was the cleaning agent used on the device and typically utilized to clean the adapters.There was no ointment utilized.Nothing unusual was observed on the device prior to use.No other products being utilized with the device.The clamps were moved to a new location after each treatment.The product was replaced/re-inserted with a new catheter (another brand) to resolve the issue.Treatment was completed.There was a small amount of blood loss and blood transfusion was not required.There was no reported patient injury.

• 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: 13153862
• MDR Text Key: 283292847
• Report Number: 3009211636-2022-00005
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006539
• UDI-Public: 10884521006539
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888135241
• Device Catalogue Number: 8888135241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2022
• Date Device Manufactured: 11/23/2019
• 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: 83 YR
• Patient Sex: Male