MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 8813817009

Device Problem Obstruction of Flow (2423)

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

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the image of the device packaging with a orange band at he distal end, a yellow ban in the middle and another orange band at the proximal end with a note stapled.The devices noted that the device were received opened with yellow and orange bands around the body of the packaging.Only one device was still in the blue packaging paper.The catheters, introducer needles, straight stainless steel guide wires, dilators, wound dressings and sealing caps appeared intact.Functional testing found the catheters were submerged into a water bath.The ends were clamped, and a syringe was used to inject air to observe leakage and no air bubbles were present.Both extensions were tested with acceptable results.The guide wires were passed through the lumen and no occlusion was noted.It was reported that there was product damage.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, prior to use (after package opening and subsequent flushing with normal saline), it was stated that the devices lumen was found to be occluded (damage), there were no damage on the product and packaging upon receipt, it just opened and identified blocked lumen.There was no other parts of device missing, the device was sealed upon receipt, there was no patient involvement.

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.

Event Description

According to the reporter, prior to use (after package opening and subsequent flushing with normal saline), it was stated that the devices arterial lumen was found to be occluded (damage), there were no damage on the product and packaging upon receipt, the lines was not reversed.Another kit was opened but was stated to have the same issue.There was no other parts of device missing, the kit was sealed upon receipt, there was no packaging damage.Another device was used to resolve the issue.There was no patient involvement.

• Brand Name: MAHURKAR
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 10936622
• MDR Text Key: 219546746
• Report Number: 3009211636-2020-00295
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004917
• UDI-Public: 10884521004917
• Combination Product (y/n): N
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2023
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1901500092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1