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

Model Number 8813793009

Device Problems Break (1069); Material Frayed (1262); Misassembled (1398); Misconnection (1399); Tear, Rip or Hole in Device Packaging (2385); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the catheter had an inferior quality material issue and crimped guide wire.Some guides were thicker than the tip of the catheter which you need to force.Catheter that broke on the second day of use (fracture), or broke the tips during introduction.The guide tip did not fit the needle.Low flow from the second day of use.The guide was too flexible and hinders tunneling.The internal volume of sets was smaller than other catheters.The catheter was too soft, making insertion difficult in obese patients or patients with subcutaneous fibrosis.The thinner dilator has no consistency and did not act as a dilator in patients with more skin or subcutaneous resistance.It was also stated that device had a set of complaints that leads to low durability, generating the need for frequent exchange and impairing the performance of the sessions, as well as the need to use heparin in all sessions, which many services dispute.The kit without blade and syringe.The puncture needle did not seal when connected to syringe, with air inlet.The box had no lid, it comes closed with a micropore.Bad cap that breaks and comes loose from the silicone connection.Fragile packaging.Heat sensitive catheter material, which leads to catheter deformation with body temperature alone.There was no reported patient outcome.

• 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
• MDR Report Key: 12590643
• MDR Text Key: 275218163
• Report Number: 3009211636-2021-00281
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004801
• UDI-Public: 10884521004801
• 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
• Report Date: 10/07/2021

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
• Device Operator: Health Professional
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 2023800093
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/07/2021
• Date Device Manufactured: 09/26/2020
• 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