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 the reporter, the catheter was of lower quality material and crumpled guide wire.Some guides were thicker than the end of the catheter which needed 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 had impaired the tunneling.The internal volume of the sets was smaller than the other catheters.The catheter was too soft, making it difficult to introduce in obese patient or with subcutaneous fibrosis.The thinner dilator had no consistency and did not play the role of dilator in patient with more skin or subcutaneous resistance.It was also stated that device had a set of complaints that lead to low durability of catheters generating the need for frequent change and impairing the performance of the sessions and also the need to use heparin in all sessions, which many services dispute.The kit had no blade and syringe.Puncture needle was not sealed when connected to syringe with air inlet.The box had no lid and came closed with micropore.A bad cover that broke and loosen from the connection with silicone.Fragile packaging.Thermosensitive catheter material, which lead 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: 12578353
• MDR Text Key: 274906821
• Report Number: 3009211636-2021-00275
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• 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
• Date Manufacturer Received: 09/17/2021
• 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