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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JELCO INTRAVASCULAR CATHETER

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JELCO INTRAVASCULAR CATHETER Back to Search Results
Model Number 326610
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/07/2021
Event Type  Injury  
Event Description
Smiths medical received information that a patient had an iv inserted in hand, heard a pop, and then began to bleed. Clinician reports one inch of catheter remained in patients hand. Patient underwent surgery to remove catheter.
 
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Brand NameJELCO
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12426633
MDR Text Key270093977
Report Number3012307300-2021-09197
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K160235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 09/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number326610
Device Lot Number4158490
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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