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

Model Number 8888135194

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, intraoperatively, clinician stated that there was a difference of.6ml between the printed priming volume and the actual lumen capacity, the patient was given with 5000 units of heparin per ml, this gave the patient who had embolic stroke 3000 units that went systemic thus increasing the risk of a hemorrhagic stroke, the patient spent a couple of days in the intensive care unit(icu) (intensive care unit) as heparin bolus was a major factor for the extended stay, patients' icu stay was initially for embolic stroke intervention.It was stated that priming volume printed on the catheter and in the ifu is 1.6 ml on the arterial (red) lumen and 1.7 ml on the venous (blue) lumen was not accurate.It was also stated that the "actual" volume that the catheter lumens hold is less than printed in the ifu (instructions for use) and on the catheter, tested priming volumes were over by about.4-.6ml.It was replaced with a competitors product.There was no reported patient harm and the patient was discharged after 1-2 days of additional observation from the icu.

Manufacturer Narrative

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

Event Description

According to the reporter, the patient was in the icu after suffering an embolic stroke.While administering heparin to the patient the physician noted there was a difference of.4ml to.6ml between the priming volume which is printed in the instructions for use (ifu) and on the device, and the actual capacity of the lumen.The patient was given 5,000 units of heparin/ml, which gave the patient a 3,000 unit bolus which went systemic and there was concern regarding the increased risk of a haemorrhagic stroke due to this.The catheter was replaced and the patient remained in the icu under observation for two additional days.

Manufacturer Narrative

Correction g1, h3, h6, h7 and h9 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted no abnormalities.Functional testing found that the priming volumes were measured and found to be less than the published values for the device.It was reported that a design fault was identified during product analysis.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
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 8380042
• MDR Text Key: 137708679
• Report Number: 3009211636-2019-00052
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 20884521006505
• UDI-Public: 20884521006505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2020
• Device Model Number: 8888135194
• Device Catalogue Number: 8888135194
• Device Lot Number: 1803100136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 01/03/2019; 01/03/2019
• Supplement Dates FDA Received: 06/21/2019; 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: R201904-02
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention