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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 Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
 
Event Description
Prior to use, the catheter was tested with physiologic serum and all went well.So the catheter was inserted in the patient.All was going well.Nevertheless, after 5 minutes, the catheter was blocked.There were no negative consequences for the patient, the catheter was removed and changed.
 
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 blocked.The customer returned one open kit with one snaplock adapter, one epidural catheter, and one non-teleflex syringe.The components were received connected together.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.The reported complaint of the catheter being blocked other remarks: 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
Prior to use, the catheter was tested with physiologic serum and all went well.So the catheter was inserted in the patient.All was going well.Nevertheless, after 5 minutes, the catheter was blocked.There were no negative consequences for the patient, the catheter was removed and changed.
 
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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 Key6813753
MDR Text Key83471398
Report Number3006425876-2017-00271
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 Physician
Type of Report Initial,Followup
Report Date 08/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/19/2019
Device Catalogue NumberJC-05400-B
Device Lot Number71F17F0728
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/02/2017
Initial Date FDA Received08/23/2017
Supplement Dates Manufacturer Received09/20/2017
Supplement Dates FDA Received09/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2017
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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