MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPL

Model Number	8888345629
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2021
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, at insertion into the patient's left subclavian artery using skdinger techniques, the patient was in a supine position, laying on the sterile fields, and had local anesthesia infiltrated with xylocaine 2% without vasocontrictor, the guide wire was stuck in the catheter.It did not leave without removing the catheter (it was necessary to remove the guide wire and catheter from the patient simultaneously).The guide wire was still intact when it was removed.The catheter was not repaired and there was no leak.Tego was not utilized and there was no luer adapter issue.Asepsis and antisepsis with alcoholic chlorhexidine 0.5% was used as the cleaning agent used on the device.There was observation of blood reflux through the equipment and had fixation of the catheter with mononylon wire 3-0.There was occlusive dressing and prescription (rx) control request (indication for dialysis).There was nothing unusual observed on the device prior to use and flushing was done.There were no other defects/damages found on the product.There was no problem with the catheter's dimension and there was no occlusion.The guide wire used was the one included in the kit.The catheter was replaced with a new one from another lot to resolve the issue and the procedure was completed.There was no blood loss.There was no medical or surgical intervention needed to prevent a permanent impairment of a function and it did not lead to or extend patient hospitalization.There was no patient injury.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPL
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 12302263
• Report Number: 3009211636-2021-00202
• Device Sequence Number: 14579840
• Product Code: NIE
• UDI-Device Identifier: 10884521006799
• UDI-Public: 10884521006799
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K020089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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: 09/06/2023
• Device Model Number: 8888345629
• Device Catalogue Number: 8888345629
• Device Lot Number: 1827600092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR