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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 306701
Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2018
Event Type  malfunction  
Event Description
When i opened up the package of the protectiv plus safety iv catheter, the cap fell off and the needle was bent.
 
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Brand NameJELCO
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
MDR Report Key8054595
MDR Text Key126649564
Report Number8054595
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number306701
Device Catalogue Number3067
Device Lot Number3453559
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/02/2018
Event Location Hospital
Date Report to Manufacturer11/09/2018
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

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