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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
Catalog Number 4509E
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2020
Event Type  malfunction  
Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be performed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.Model #, udi, operator of device, and report source are unknown.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).
 
Event Description
It was reported that during the use of the product, the catheter slipped off from the epidural connector.No patient injury reported.
 
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Brand Name
PORTEX CONTINUOUS EPIDURAL ANESTHESIA TRAY
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15307731
MDR Text Key305495964
Report Number3012307300-2022-16471
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K781052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number4509E
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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