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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX EPIDURAL MINIPAC SYSTEM; ANESTHESIA CONDUCTION KIT
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NULL PORTEX EPIDURAL MINIPAC SYSTEM; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/118CZ
Device Problem Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Udi information is unknown.Initial reporter also sent report to fda is unknown.No information has been provided to date.Manufacturing site address is unknown.Premarket (510k) number is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Reported failure was unable to be reproduced.Root cause cannot be determined since the complaint was not confirmed due to the fact the sample was tested and successfully passed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
 
Event Description
It was reported that disconnection occurred between the epidural catheter connector and the tubing.No patient injury was reported.
 
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Brand Name
PORTEX EPIDURAL MINIPAC SYSTEM
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15401829
MDR Text Key305889984
Report Number3012307300-2022-18661
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number100/391/118CZ
Device Lot Number3869444
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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