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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 OU-05500-NRON
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2021
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 plunger of lor syringe did not slide during preparation for the procedure. Therefore, a new kit was opened instead.
 
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Brand NameEPIDURAL CATHETERIZATION KIT NRFIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11894465
MDR Text Key256222353
Report Number3006425876-2021-00518
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 05/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberOU-05500-NRON
Device Lot Number71F20H3119
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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