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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT NRFIT

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ARROW INTERNATIONAL INC. 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. ).
 
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Brand NameEPIDURAL CATHETERIZATION KIT NRFIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12017055
MDR Text Key260044913
Report Number3006425876-2021-00587
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
0 Patients were 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
Device Catalogue NumberASK-05500-NRON
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
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

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