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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 Problems Difficult to Remove (1528); Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A device history record review was performed on the epidural catheter and needle with no relevant findings. 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 epidural catheter and needle with no relevant findings. The potential cause of issues with the catheter and needle could not be determined based upon the information provided and without a sample.
 
Event Description
It was reported that during an accidental removal of the catheter while removing it through the needle, the catheter scratched in the needle. The catheter slips incorrectly in the needle. It happened three times. The staff had to insert the epidural needle with a new kit. The patient's condition was reported as good.
 
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 during an accidental removal of the catheter while removing it through the needle, the catheter scratched in the needle. The catheter slips incorrectly in the needle. It happened three times. The staff had to insert the epidural needle with a new kit. The patient's condition was reported as good.
 
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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 Key7221633
MDR Text Key194232931
Report Number3006425876-2018-00065
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 01/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/17/2019
Device Catalogue NumberJC-05400-B
Device Lot Number71F17M0875
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 Received02/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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