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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-E
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A device history record review was performed on the epidural catheter, snaplock adapter, and flat filter with no relevant findings. The ifu for this kit, cz-05400-108a; rev. 2, was reviewed as a part of this complaint investigation. The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage. Do not apply additional tension on the catheter if catheter begins to stretch excessively. Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal. During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position. " a corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample. Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed on the catheter, snaplock adapter and filter with no other remarks: evidence to suggest a manufacturing related cause. The potential cause of this complaint could not be determined based upon the information provided and without a sample.
 
Event Description
It was reported that the epidural catheter disconnected. It was evaluated; it was properly fixed to the skin without deterioration of the dressings and the distal end catheter of the filter was observed to be disconnected. The epidural catheter was replaced. There was no patient injury.
 
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
It was reported that the epidural catheter disconnected. It was evaluated; it was properly fixed to the skin without deterioration of the dressings and the distal end catheter of the filter was observed to be disconnected. The epidural catheter was replaced. 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 INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX 31114
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key7228480
MDR Text Key254425700
Report Number3003737899-2018-00010
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeCO
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 01/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue NumberJC-05400-E
Device Lot Number14F17F0305
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 Received02/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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