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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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SMITHS MEDICAL ASD, INC. JELCO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 326010
Device Problems Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 09/21/2021
Event Type  malfunction  
Event Description
Went to start patient¿s iv and needle completely folded and bent. Not usable.
 
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Brand NameJELCO
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
MDR Report Key12688380
MDR Text Key278103861
Report Number12688380
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number326010
Device Catalogue Number3260
Device Lot Number4158455
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/14/2021
Event Location Hospital
Date Report to Manufacturer10/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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