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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL JELCO PLUS CATHETER INTRAVASCULAR THERAPEUTIC

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NULL JELCO PLUS CATHETER INTRAVASCULAR THERAPEUTIC Back to Search Results
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2022
Event Type  malfunction  
Event Description
It was noted that upon removal of the needle, the needle would not engage and secure in the safety sheath. Part of the needle was exposed.
 
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Brand NameJELCO PLUS
Type of DeviceCATHETER INTRAVASCULAR THERAPEUTIC
Manufacturer (Section G)
NULL
MDR Report Key14599420
MDR Text Key293863080
Report Number3012307300-2022-10511
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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