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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 AK-05502
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2018
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 needle is causing false loss of resistance. The problem was described as the tuohy tip being less pronounced so the tip of the needle does not fully enter the epidural space causing difficulty in threading the catheter.
 
Manufacturer Narrative
(b)(4). No lot number was 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 needle and lor syringe with no relevant findings. A review of design change history for part number kz-05500-007 was performed as a part of this investigation. No design changes have been made to this product 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. No lot number was 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 needle and lor syringe with no evidence to suggest a manufacturing related cause. Therefore, 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 needle is causing false loss of resistance. The problem was described as the tuohy tip being less pronounced so the tip of the needle does not fully enter the epidural space causing difficulty in threading the catheter.
 
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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 Key7674109
MDR Text Key113551206
Report Number1036844-2018-00184
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAK-05502
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 Received07/27/2018
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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