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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 307300
Device Problems Material Frayed (1262); Product Quality Problem (1506); Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 02/25/2022
Event Type  malfunction  
Event Description
Nearly 20 reports of catheter tips fraying upon insertion, needle poking through catheter tip, needle tip being bent prior to packaging opening, and catheter flimsy enough to be bent with air being blown on it causing multiple sticks upon iv insertion.
 
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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 Key13807795
MDR Text Key287405244
Report Number13807795
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10351688071293
UDI-Public(01)10351688071293
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number307300
Device Lot Number4169776
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2022
Event Location Hospital
Date Report to Manufacturer03/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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