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

Model Number 8888135191

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/14/2022

Event Type  malfunction  

Event Description

According to the reporter, before use, inconsistencies were found with the new shipping product.The standard 8888135191 central venous catheter set for hemodialysis was a straight catheter and the 8888135162 standard hemodialysis central venous catheter set was a curved catheter.When using the new batch of straight catheter, it was found that the straight catheters of 1.3ml and 1.3ml were marked with the actual straight catheters of different capacities without changing the manufacturer, specification and model.The problem was reported to the manufacturer.The manufacturer feedback: the marked 1.5ml and 1.6ml curved catheters were wrongly marked and the actual volumes were 1.1ml and 1.2ml; the previously marked 1.6ml and 1.7ml straight catheters were wrongly marked and the actual volumes were 1.3 ml, 1.3ml.It was mentioned that heparin sodium injection was mostly used and this was a clinical concern regarding the volume of sealing fluid indicated on the label.According to the volume of the catheter, the volume of the sealing solution was 0.1ml.The parameters of the consumables were found to be inconsistent with the new delivery product.The company's initial evaluation of the incident device found during visual inspection of the returned photo noted that the priming values listed on the packaging were 1.6 and 1.7ml instead of 1.3ml.The listed values are that of the theoretical priming volumes which differ from the measured volumes.There was no patient involvement.

Manufacturer Narrative

D10 concomitant product: 8888135162 - 8888135162 13.5fr 16cm mahka q+ ce kit, lot# 1932300174 8888135162 - 8888135162 13.5fr 16cm mahka q+ ce kit, lot# 1932300175 8888135191 - 8888135191 13.5frx19.5cm mahka q+ sekit, lot# 2009300098 8888135191 - 8888135191 13.5frx19.5cm mahka q+ sekit, lot# 2009300098 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted the published lumen priming volume was found to be incorrect.It was reported that there was an issue with the labelling.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18485901
• MDR Text Key: 333096121
• Report Number: 3009211636-2024-00015
• 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: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2024

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: 2009300098
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2020
• 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