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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 EC-05500
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/12/2018
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
It was reported that a user found that the catheter came off the snap lock adaptor at a patients ward. According to the hospital, any tension was unlikely to be applied by the patient since he/she was not in the condition of being able to change position by him/herself. As a result of this issue, the catheter was removed and replaced by a new one.
 
Manufacturer Narrative
(b)(4). A device history record review could not be performed as no lot number was provided by the customer. 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. The device history records were not reviewed as no lot number was provided by the customer. Therefore, the potential cause of the catheter disconnecting from the snaplock adapter could not be determined based upon the information provided and without a sample.
 
Event Description
It was reported that a user found that the catheter came off the snap lock adaptor at a patients ward. According to the hospital, any tension was unlikely to be applied by the patient since he/she was not in the condition of being able to change position by him/herself. As a result of this issue, the catheter was removed and replaced by a new one.
 
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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 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 Key7370111
MDR Text Key103527476
Report Number3006425876-2018-00174
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
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 03/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC-05500
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 Received04/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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