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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JC-05400-B
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2018
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
It was reported that the plunger's syringe is leaking. Leak of sterile water. There was no patient injury.
 
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed on the lor syringe with no evidence to indicate a manufacturing related issue. Therefore, the potential cause of the syringe leaking could not be determined based upon the information provided and without the sample.
 
Event Description
It was reported that the plunger's syringe is leaking. Leak of sterile water. There was no patient injury.
 
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Brand NameEPIDURAL CATHETERIZATION SET
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key7757693
MDR Text Key116378168
Report Number3006425876-2018-00524
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/18/2020
Device Catalogue NumberJC-05400-B
Device Lot Number71F18C1794
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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