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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT
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NULL PORTEX EPIDURAL CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 100/391/118CZ
Device Problem Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
Report source unknown.No information has been provided to date.A product sample was received for evaluation.Visual and functional testing were performed.One used decontaminated sample was received in plastic bag for investigation.Syringe was received disassembled into two parts.Supplier investigation didn't identify the root cause of this issue.No lot number was provided; therefore, device history record review could not be completed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
Event Description
It was reported that there was resistance when using the device during the insertion procedure.No patient injury was reported.
 
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Brand Name
PORTEX EPIDURAL CONTINUOUS TRAYS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15363135
MDR Text Key305151516
Report Number3012307300-2022-17976
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number100/391/118CZ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2020
Was the Report Sent to FDA? No
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? Yes
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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