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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO PLUS CATHETER, INTRAVASCULAR, THERAPEUTIC

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SMITHS MEDICAL ASD, INC. JELCO PLUS CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number 306701
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2022
Event Type  malfunction  
Event Description
It was noted that upon removal of the needle, the needle would not engage and secure in the safety sheath. Part of the needle was exposed.
 
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Brand NameJELCO PLUS
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
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 Key14599419
MDR Text Key293334797
Report Number3012307300-2022-10509
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number306701
Device Lot Number4188189
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/02/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/26/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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