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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 Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Date 12/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) the device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
 
Event Description
The catheter was successfully inserted for a parturient woman.Then the physician experienced an abnormal resistance during injection of the anesthetic, leading to the need of inserting a new catheter.The patient's condition was reported as unknown.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was not injecting medication.The customer returned one epidural catheter, one snaplock adapter, and one 5ml syringe.The catheter and snaplock adapter were received connected together (reference attached files (b)(4)).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears typical but used.Adhesive material can be seen on the outer extrusion of the catheter.No other defects or anomalies were observed.A manual flow test was performed using the returned catheter and snaplock adapter.A 20ml lab inventory syringe was connected to the returned snaplock adapter and catheter.Using hand pressure, the water was injected.Water could be seen immediately exiting the distal end of the catheter.No blockages were found.Other remarks: a corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of the catheter not injecting medication could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned components passed a functional flow test.There were no functional issues found with the returned sample.
 
Event Description
The catheter was successfully inserted for a parturient woman.Then the physician experienced an abnormal resistance during injection of the anesthetic, leading to the need of inserting a new catheter.The patient's condition was reported as unknown.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA 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 Key6258465
MDR Text Key65033030
Report Number3006425876-2017-00003
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2018
Device Catalogue NumberJC-05400-B
Device Lot Number71F16K1493
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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