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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

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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); Product Quality Problem (1506); Defective Component (2292); Tear, Rip or Hole in Device Packaging (2385); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 product was of inferior quality material, crimped guide wire. Some guides were thicker than the tip of the catheter and they need to force it. The catheter broke on the second day of use (fracture), or broke the tips during introduction. The guide tip did not fit the needle. There was a low flow from the second day of use. The guide was too flexible and hindered 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 had no consistency and did not act as a dilator in patients with more skin or subcutaneous resistance. The set of complaints above led to the low durability of the catheter, 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 was without blade and syringe. Puncture needle did not seal when connected to syringe, with air inlet. The box had no lid, it came closed with a micropore. There was a bad cap that was broken and came loose from the silicone connection. Fragile packaging. Heat sensitive catheter material, which led to catheter deformation with body temperature alone. There was no patient injury.
 
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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
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 Key12589708
MDR Text Key275183274
Report Number3009211636-2021-00279
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2021
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
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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