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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 308700
Device Problem Detachment Of Device Component (1104)
Patient Problem Blood Loss (2597)
Event Date 07/25/2017
Event Type  malfunction  
Event Description
Started iv in usual pattern using 20 gauge angio. Obtained blood return and advanced catheter until it clicked. Retracted needle without loosening connection or detaching angio from hub. Applied tegaderm and then angio detached from hub. Blood started to run down the hand. Immediately applied digital pressure to minimize blood loss. Proceeded to connect iv tubing to hub, taped tubing to hand and then wiped off blood. The 20g angio lot# 3417461.
 
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Brand NameJELCO
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
1265 grey fox rd.
saint paul MN 55112
MDR Report Key6773193
MDR Text Key82029145
Report Number6773193
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number308700
Device Lot Number3417461
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/03/2017
Event Location Hospital
Date Report to Manufacturer08/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/08/2017 Patient Sequence Number: 1
Treatment
NO
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