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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX EPIDURAL; CONTINOUS TRAYS
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX EPIDURAL; CONTINOUS TRAYS Back to Search Results
Lot Number 200529
Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2020
Event Type  malfunction  
Manufacturer Narrative
3 flat filters and 11 sets of stock items were returned.Was revealed in the investigation log.Defective component (nr fit flat filter), item number: 30-4451, lot number: 816901, dhr review was completed.Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.
 
Event Description
Information received a smiths medical epidural was leaking medical fluid of unknown medication through the filter, during the use of the product.No patient injury was reported.
 
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Brand Name
PORTEX EPIDURAL
Type of Device
CONTINOUS TRAYS
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
olomoucka 306
hranice 1, mesto 753 0 1
EZ  753 01
MDR Report Key10549026
MDR Text Key207417849
Report Number3012307300-2020-09456
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial
Report Date 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date05/29/2023
Device Lot Number200529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2020
Was the Report Sent to FDA? No
Date Manufacturer Received08/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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