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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX EPIDURAL FILTERS FILTER, CONDUCTION, ANESTHETIC

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SMITHS MEDICAL ASD, INC PORTEX EPIDURAL FILTERS FILTER, CONDUCTION, ANESTHETIC Back to Search Results
Model Number 24-1000-64
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/25/2020
Event Type  malfunction  
Event Description
It was reported that the customer connected the product (a flat filter) to a third party's product and started administration of medical fluid. About 7 hours later, medical fluid leaked from the filter. No patient injury or complications were reported in relation to this event.
 
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Brand NamePORTEX EPIDURAL FILTERS
Type of DeviceFILTER, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC
3350 granada avenue north
suite 100
oakdale, mn
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, mn 
MDR Report Key10048951
MDR Text Key190683029
Report Number3012307300-2020-04010
Device Sequence Number1
Product Code BSN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24-1000-64
Device Catalogue Number24-1000-64
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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