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

Model Number 8888135241

Device Problem Material Puncture/Hole (1504)

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

Event Date 11/20/2021

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 patient was admitted to the icu for a long time due to brain trauma and was treated with crrt or continuous renal replacement therapy for hemodialysis due to acute renal failure.The catheter was implanted on the patient for one day and the patient was on the machine for treatment on (b)(6) 2021 at 20:30 and the crrt dialysis machine alarmed for blood coagulation at about 3:00 on (b)(6) 2021.After the nurse checked it, the dialysis catheter had local oozing blood and it was found at the venous extension tube.There was a rupture about the size of a needle at the tip of the catheter.A crack was observed at the extension tube near the connector.It was reported to the doctor immediately.After careful examination by the doctor, the patient got off the machine.On (b)(6) 2021 at 5:00, the patient was on the machine again for treatment.This event caused the patient to undergo a second puncture (extubated the tube and performed re-catheterization) and treatment was not smooth which affected the patient's crrt.The patient suffered second pain.The catheter was replaced to resolve the issue.Tego was not utilized.There was no luer adapter issue.There was no cleaning agent used on the device.The insertion site was treated with iodophor prior to product placement and iodophor was typically utilized to clean the adapters.Nothing unusual was observed on the device prior to use.Flushing was done and had a normal outcome.No other damages were found on the product aside from the reported issue.Crrt machine was being utilized with the device.The cleaning agents allowed to dry thoroughly prior to applying ointment to the area.There was a small amount of blood loss and blood transfusion was not required.There was no reported patient outcome.

Event Description

According to the reporter, the patient was admitted to the icu for a long time due to brain trauma and was treated with crrt or continuous renal replacement therapy for hemodialysis due to acute renal failure.The catheter was implanted on the patient for one day and the patient was on the machine for treatment on (b)(6) 2021 at 20:30 and the crrt dialysis machine alarmed for blood coagulation at about 3:00 on (b)(6) 2021.After the nurse checked it, the dialysis catheter had local oozing blood and it was found at the venous extension tube and a crack was observed at the venous extension tube near the luer adapter.It was reported to the doctor immediately.After careful examination by the doctor, the patient got off the machine.On (b)(6), 2021 at 5:00, the patient was on the machine again for treatment.This event caused the patient to undergo a second puncture (extubated the tube).Treatment was not smooth because re-catheterization was performed and treatment was delayed for about 4 hours which affected the patient's c rrt.The patient suffered second pain.The catheter was replaced to resolve the issue.Tego was not utilized.There was no luer adapter issue.There was no cleaning agent used on the device.The insertion site was treated with iodophor prior to product placement and iodophor was typically utilized to clean the adapters.Nothing unusual was observed on the device prior to use.Flushing was done and had a normal outcome.No other damages were found on the product aside from the reported issue.Crrt machine was being utilized with the device.The cleaning agents were allowed to dry thoroughly prior to applying ointment to the area.There was a small amount of blood loss and blood transfusion was not required.There was no reported patient injury.

Manufacturer Narrative

Additional information: b5, g3, h6 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: 13024719
• MDR Text Key: 282482714
• Report Number: 3009211636-2021-00371
• 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: 01/06/2022

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: 8888135241
• Device Catalogue Number: 8888135241
• Device Lot Number: 2106900067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 12/19/2021
• Supplement Dates FDA Received: 01/06/2022
• Date Device Manufactured: 04/30/2021
• 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: 70 YR
• Patient Sex: Male