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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX CONTINUOUS EPIDURAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT
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NULL PORTEX CONTINUOUS EPIDURAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT Back to Search Results
Lot Number 3873020
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2020
Event Type  malfunction  
Event Description
It was reported that the epidural connector broke.No patient injury reported.
 
Manufacturer Narrative
Manufacturing device history record review was not performed because it is a supplier design issue.A product sample was received for evaluation.Visual testing was performed.Visual inspection found the connector has broken hinge.The root cause of the reported issue was found to be a design issue.An internal scar has been opened and the supplier recommended a redesign of the hinge area.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.No information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
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Brand Name
PORTEX CONTINUOUS EPIDURAL ANESTHESIA TRAY
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15357569
MDR Text Key304970880
Report Number3012307300-2022-17788
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K781052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number3873020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/13/2022
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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