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

Model Number 8813817009

Device Problems Material Frayed (1262); Difficult to Remove (1528)

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

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, after flushing was done successfully during the catheter insertion procedure, the guide wire was not passing through the arterial lumen of the first catheter.The faulty catheter and guidewire were removed and discarded.It was mentioned that it was necessary to remove the guide wire and catheter from the patient simultaneously (in one action) due to the alleged defect.When the guide wire was removed, it was observed that the guide wire was still intact and was coiled.When the other 4 catheters in the box were checked for the same event and patient, similar issue of guide wire not passing through the lumen was noted when they tried to use the other 4 catheters to the patient.The catheters were not repaired and there was no leak.Betadine and chlorhexidine was used as cleaning agents on the devices.Tego was not utilized and there was no luer adapter issue.Betadine was also used as a cleaning agent on the insertion site prior to product placement.There was no damage to the devices' box and packaging.There was no excessive force used to pull/take out the products and nothing unusual was observed on the devices prior to use.No other products were being utilized with the devices and there were no other defects/damages found on the products.There were no problems with the catheters'' dimensions and there was no occlusion.The guide wires used were the ones included in the kits.There was no blood loss.Acute dialysis catheterization was performed as a result of the event and the procedure was completed.There was no patient injury.

• 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: 11327306
• MDR Text Key: 231946202
• Report Number: 3009211636-2021-00040
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004917
• UDI-Public: 10884521004917
• 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
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1913000194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2021
• Date Device Manufactured: 05/17/2019
• 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