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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION COMPONENT; ANESTHESIA CONDUCTION CATHETER
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION COMPONENT; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Catalog Number EC-05500
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the md felt that the catheter was softer than usual and had difficulty in placement of the catheter at the 2 operations; he/she had to insert and pull out the catheter several times for placement.There was no problem on the other 4 catheters that the md placed on different days.
 
Manufacturer Narrative
(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.A review of design change history for part number kz-05400-002 was performed as a part of this investigation.No design changes have been made to this part in the past two years that would have led to this complaint.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 lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of the catheter being too soft could not be determined based upon the information provided and without a sample.
 
Event Description
It was reported that the md felt that the catheter was softer than usual and had difficulty in placement of the catheter at the 2 operations; he/she had to insert and pull out the catheter several times for placement.There was no problem on the other 4 catheters that the md placed on different days.
 
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Brand Name
EPIDURAL CATHETERIZATION COMPONENT
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9233865
MDR Text Key167003248
Report Number3006425876-2019-00823
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
PMA/PMN Number
K140110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEC-05500
Was Device Available for Evaluation? No
Date Manufacturer Received11/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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