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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO PROTECTIV SAFETY IV CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

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SMITHS MEDICAL ASD, INC. JELCO PROTECTIV SAFETY IV CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Catalog Number 306639
Device Problem Defective Component (2292)
Patient Problem Bruise/Contusion (1754)
Event Type  malfunction  
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Brand NameJELCO PROTECTIV SAFETY IV CATHETERS
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15105326
Report Number3012307300-2022-14238
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K990236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number306639
Device Lot Number4197545
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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