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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL JELCO IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

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NULL JELCO IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L Back to Search Results
Catalog Number 4033-AB
Device Problems Break (1069); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the device has a plastic part that is not very malleable, thus breaking the patient's vessel more easily.
 
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Brand NameJELCO IV CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
Manufacturer (Section G)
NULL
MDR Report Key14516623
MDR Text Key293145137
Report Number3012307300-2022-09733
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4033-AB
Device Lot Number3989930
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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