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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL EPIFUSE EPIDURAL CATHETER CONNECTOR; ANESTHESIA CONDUCTION KIT
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NULL EPIFUSE EPIDURAL CATHETER CONNECTOR; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 30-4498-001
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
A sample was received to perform an investigation.Visual inspection of the sample confirmed that the hinge part of the connector was damaged.A device history record (dhr) review could not be performed as the lot number was unknown.Potential causes were that the production worker did not notice any damage during the inspection or the hinges were cracked during transportation.The supplier was notified of this event.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
 
Event Description
It was reported that immediately after opening the package, the user noticed the connector was broken into two.No patient injury was reported.
 
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Brand Name
EPIFUSE EPIDURAL CATHETER CONNECTOR
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15347842
MDR Text Key305513424
Report Number3012307300-2022-17422
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number30-4498-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2020
Was the Report Sent to FDA? No
Date Manufacturer Received04/20/2022
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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