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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/Blood 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.
 
Manufacturer Narrative
One portex epidural filter was returned with a third-party connector attached for analysis.Water was injected from a syringe through the connected; no leakage observed.Water was then injected into the flat filter alone; no leakage confirmed.Based on the evidence, there was no fault found as the complaint was not confirmed.
 
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Brand Name
PORTEX EPIDURAL FILTERS
Type of Device
FILTER, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis, mn
MDR Report Key10048951
MDR Text Key190683029
Report Number3012307300-2020-04010
Device Sequence Number1
Product Code BSN
UDI-Device Identifier15019517054651
UDI-Public15019517054651
Combination Product (y/n)N
PMA/PMN Number
K172410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/12/2020
Supplement Dates Manufacturer Received05/25/2020
Supplement Dates FDA Received06/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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