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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO® PROTECTIV® SAFETY I.V. CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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SMITHS MEDICAL ASD, INC. JELCO® PROTECTIV® SAFETY I.V. CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 306601
Device Problems Device Alarm System (1012); Difficult to Advance (2920)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 03/08/2019
Event Type  malfunction  
Event Description
Information was received that while a smiths medical catheter was in use, device was difficult to thread. No patient injury resulted.
 
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Brand NameJELCO® PROTECTIV® SAFETY I.V. CATHETERS
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD
201 west queen street
southington CT 06489
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key8494216
MDR Text Key141323772
Report Number3012307300-2019-01876
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
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 05/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/06/2021
Device Catalogue Number306601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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