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

Model Number 8888135191

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)

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

Event Date 09/02/2020

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 interface of the device's tube was damaged.It was also stated that they found an oozing of blood around the interface of the device, and it was impossible to continue the treatment.Re-catheterization was performed, but it caused delay of the treatment.There was no reported patient injury.

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 interface of the device's arterial tube was damaged.It was also stated that they found an oozing of blood (close to hub) around the interface of the device and it was impossible to continue the treatment.Re-catheterization was performed but it caused for the delay of the treatment.The treatment was completed, there was no blood loss, blood transfusion was not required, nothing unusual was observed on the device prior to use, normal saline was used for flushing with a normal result and there was no other products being utilized with the device.It was also mentioned that there was no other defects/damages found on the product where the leak was observed, the blood of the patient was safely returned, tego was not utilized, there was no luer adapter issue, iodophor disinfectant was used to treat the insertion prior to product placement and there was no medical intervention done to the patient.There was no damage to the device's external packaging and box.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
• MDR Report Key: 10933998
• MDR Text Key: 219174019
• Report Number: 3009211636-2020-00294
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (y/n): N
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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: 1927500118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR