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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number CA-02220
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2017
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
The filter and black and blue connectors come apart spontaneously during use. The product was attached by a physician, and checked hourly. At one of the hourly checks, the tubing and filter had come apart. The catheter was removed and replaced.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the flat filter and snaplock adapter with no relevant findings. A corrective action is not required at this time as a potential 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 flat filter and snaplock adapter with no relevant findings. Therefore, the potential cause of the filter disconnecting from the snaplock adapter could not be determined based upon the information provided and without a sample.
 
Event Description
The filter and black and blue connectors come apart spontaneously during use. The product was attached by a physician, and checked hourly. At one of the hourly checks, the tubing and filter had come apart. The catheter was removed and replaced.
 
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Brand NameEPIDURAL CATHETERIZATION KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key6568739
MDR Text Key75308104
Report Number1036844-2017-00192
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeCA
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 04/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2018
Device Catalogue NumberCA-02220
Device Lot Number13F16M0121
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 Received06/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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