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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL IMPLANTABLE PORTS DELTEC GRIPPER NEEDLES SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL IMPLANTABLE PORTS DELTEC GRIPPER NEEDLES SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-2733-24
Device Problem Fluid Leak (1250)
Patient Problem Coma (2417)
Event Date 06/21/2019
Event Type  Injury  
Manufacturer Narrative
Potential lot number for the device: 3677354.
 
Event Description
Information was received that while a smiths medical implantable port was in use, fluid built around the port a cath. Patient was admitted to the hospital for removal of the port a cath and the patient became in a comatose state. No further information has been received.
 
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Brand NameSMITHS MEDICAL IMPLANTABLE PORTS DELTEC GRIPPER NEEDLES
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, MN 55442
MDR Report Key9101004
MDR Text Key159452128
Report Number3012307300-2019-05023
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K870866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number21-2733-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/20/2019 Patient Sequence Number: 1
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