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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
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the connector detached itself from the system.No patient injury was reported.
 
Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be performed.A product sample was received for evaluation.Visual testing was performed.Visual inspection found the rotating collar (luer lock) is missing on returned filter.Each flat filter contains retention edge which is designed to hold rotating collar connected with filter.Retention edge on returned sample was found to be damaged and therefore it could not hold rotating collar in place.The root cause of the reported issue was found to be user overtightening the connection.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 Key15364988
MDR Text Key305812136
Report Number3012307300-2022-18023
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K781052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/12/2022
Initial Date FDA Received09/06/2022
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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