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

Model Number 8813817009

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during the procedure, the guidewire was stuck while inserting the catheter into the patient. The guidewire did not come out of the venous end of ultem adapter and it got stuck inside the catheter. It was also stated that the hcp (healthcare professional) had to use a new catheter and betadine was used as cleaning agent(s) for the device. The catheter was not repaired and there was no leak. There was no luer adapter issue and the insertion site was not treated prior to product placement. There were no patient symptoms or complications associated with the event and tego was not utilized. It was also mentioned that the guidewire provided with the kit was being used and there was no blood leak. Blood transfusion was not need and the procedure was completed. Flushing was done prior to product placement and there was no any medical intervention done to the patient. The guidewire and catheter were removed simultaneously. When the guidewire was removed, the device was not intact but all pieces were accounted for. There was no patient injury.

Manufacturer Narrative

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

• 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
• MDR Report Key: 10004325
• MDR Text Key: 193689455
• Report Number: 3009211636-2020-00090
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Followup,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/08/2022
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1703900091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No