• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAHURKAR
Type of DeviceCATHETER, 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 Key12578353
MDR Text Key274906821
Report Number3009211636-2021-00275
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K943349
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813793009
Device Catalogue Number8813793009
Device Lot Number2023800093
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-