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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 TU-05500-NRON
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4). The device investigation is pending. Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the user felt resistance when inserting the catheter into the epidural needle during a pretest before use on a patient. Therefore, a new kit was used instead.
 
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Brand NameEPIDURAL CATHETERIZATION KIT NRFIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9884739
MDR Text Key186730721
Report Number3006425876-2020-00281
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 03/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/11/2021
Device Catalogue NumberTU-05500-NRON
Device Lot Number71F19L0359
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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