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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION COMPONENT ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION COMPONENT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number EC-05000
Device Problems Material Separation (1562); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
 
Event Description
Received via medwatch# (b)(4). It was reported that there were 2 catheters which are defective: one was bent and the second one shredded.
 
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Brand NameEPIDURAL CATHETERIZATION COMPONENT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9693989
MDR Text Key179411057
Report Number1036844-2020-00062
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K801912
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 02/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC-05000
Device Lot Number13F18C0518
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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