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

Model Number	8813817009
Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: 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: 11327306
• Report Number: 3009211636-2021-00040
• Device Sequence Number: 16358472
• Product Code: FOZ
• UDI-Device Identifier: 10884521004917
• UDI-Public: 10884521004917
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K943349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2024
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1913000194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1