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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 SJ-05501
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Information (3190)
Event Date 06/29/2018
Event Type  malfunction  
Manufacturer Narrative
Qn#: (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 there is difficulty with passing the catheter out the end of the tuohy. One patient's dura was punctured unintentionally with this product.
 
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 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. The potential cause of catheter not advancing could not be determined based upon the information provided and without a sample.
 
Event Description
It was reported that there is difficulty with passing the catheter out the end of the tuohy. One patient's dura was punctured unintentionally with this product.
 
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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 Key7703888
MDR Text Key114546191
Report Number1036844-2018-00206
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 06/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSJ-05501
Device Lot NumberUNKNOWN
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 Received08/14/2018
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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