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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPACK; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPACK; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/118CZ
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 10/03/2019
Event Type  malfunction  
Manufacturer Narrative
Foreign report source: (b)(6).User facility: (b)(6).
 
Event Description
Information was received that a smiths medical portex epidural minipack filter leaked during a pre-test check.There were no adverse effects.
 
Manufacturer Narrative
Device evaluation: one smiths medical portex epidural continuous tray was returned for analysis.Visual inspection was performed, and it was noted that rotating collar was missing on returned filter.Each flat filter contained retention edge which is designed to hold rotating collar connected with filter.It was also noted that retention edge on returned sample was found to be damaged and therefore it could not hold rotating collar in place.The returned sample was also tested by syringe filled with water and could be confirmed that no leakage was observed.Based on the investigation results, it was believed that the reported leakage was due to rotating collar detachment which was caused by overtightening by user which conflicted with instructions for use.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be user interface.
 
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Brand Name
PORTEX EPIDURAL MINIPACK
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9311754
MDR Text Key176419885
Report Number3012307300-2019-06333
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 distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Catalogue Number100/391/118CZ
Device Lot Number3536773
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Date Manufacturer Received01/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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