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.

• 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
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 10936622
• MDR Text Key: 219546746
• Report Number: 3009211636-2020-00295
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

0 Patients were 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

• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial