MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR ELITE; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888222316

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the reporter, during procedure, when the doctor was inserting the catheter in intensive care unit (icu) to start continuous renal replacement therapy (crrt), the guide wire kept bending and it took three attempts and three different kits to place the line.Each attempt was completed with new kit, new catheter and new wire.The first kit that had the issue was replaced by a second kit with the same lot which also had the same issue.The third kit with the same item number was used on the same day of the event, immediately following unsuccessful attempts on the first two.The third kit was used successfully and the procedure was completed.It was stated that the bent/issue with the guide wire was not noticed in the packaging.There were no pieces to be retrieved.There was a resistance when inserting or withdrawing the guidewire.The guide wire used was the one included in the kit.Nothing unusual was observed on the device prior to use.No other products were being utilized with the device.No visible defect or damage was noted with the catheter or puncture needle.The catheter was not repaired, there was no leak, tego was not utilized, and there was no luer adapter issue.There was no blood loss.No additional medical or interventional treatments were provided as a result of the bent guidewire/line placement.The patient's status at the time of the event was alive but in icu.The patient did not experience any harms, symptoms or complications as a result of the reported event with the bent guidewire/line placement.The patient died as a result of illness after eventual successful placement of the acute catheter.The patient death was not related to the catheter.

• Brand Name: MAHURKAR ELITE
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12665159
• MDR Text Key: 277383929
• Report Number: 3009211636-2021-00292
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521126473
• UDI-Public: 10884521126473
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: 8888222316
• Device Catalogue Number: 8888222316
• Device Lot Number: 2104600199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/20/2021
• 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
• Patient Outcome(s): Death