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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC DELTEC SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC DELTEC SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-2767-24
Device Problem Leak/Splash (1354)
Patient Problems Extravasation (1842); Patient Problem/Medical Problem (2688)
Event Date 09/04/2019
Event Type  Injury  
Event Description
It was reported that an epirubicin extravasasion was observed. The infusion was stopped as a result. A physician was informed of the incident. The physician subsequently explanted the existing porth-a-cath and replaced it with a new one. The explanted porth-a-cath was discarded by the facility. Following the incident, the patient experienced left subclavicular pain, eurytheme, and localized heat. No further adverse effects/patient complications were reported in relation to this event.
 
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Brand NameDELTEC
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC
3350 granada avenue north
suite 100
oakdale MN 55128
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key9135776
MDR Text Key160611796
Report Number3012307300-2019-05481
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number21-2767-24
Device Lot Number3829640
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/30/2019 Patient Sequence Number: 1
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