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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT NRFIT
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EPIDURAL CATHETERIZATION KIT NRFIT Back to Search Results
Catalog Number ASK-05500-NRON
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/11/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
The filter got detached during use on a patient.Therefore, the catheter and the filter were replaced with a new kit.According to the user, the rotatable collar was not detached from the filter; it seemed that the filter itself was loose so that rotated to be detached.Also, the same issue had occurred once in april and 4 times in may.(however, they had not been reported to teleflex (b)(4) as complaints.).
 
Manufacturer Narrative
Qn# (b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the flat filter with no relevant findings.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was returned for analysis.A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the flat filter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.
 
Event Description
The filter got detached during use on a patient.Therefore, the catheter and the filter were replaced with a new kit.According to the user, the rotatable collar was not detached from the filter; it seemed that the filter itself was loose so that rotated to be detached.Also, the same issue had occurred once in april and 4 times in may.(however, they had not been reported to teleflex japan as complaints.).
 
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Brand Name
EPIDURAL CATHETERIZATION KIT NRFIT
MDR Report Key12016924
MDR Text Key260047928
Report Number3006425876-2021-00586
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASK-05500-NRON
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/26/2021
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
Type of Device Usage N
Patient Sequence Number1
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