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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAHURKAR CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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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 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.
 
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Brand NameMAHURKAR
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12578223
MDR Text Key274906421
Report Number3009211636-2021-00273
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

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