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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION COMPONENT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number EC-05000
Device Problem Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2019
Event Type  Injury  
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 while performing a lumbar epidural with ec-05000 and 17g tuohy needle, the catheter sheared off during repositioning. Additional information: during removal the catheter met resistance as it was being withdrawn. The catheter became uncoiled and remained entrapped. The patient required surgical removal. The catheter was removed under microscopic dissection by the neurosurgeon. It was found to be kinked in the ligamentum flavum. The tip was intact with a slight kink however the more proximal portion was uncoiled. The patient is doing very well and did not have any complications.
 
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Brand NameEPIDURAL CATHETERIZATION COMPONENT
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 Key8460403
MDR Text Key140179974
Report Number1036844-2019-00267
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K801912
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 03/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC-05000
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 Received04/23/2019
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

Patient Treatment Data
Date Received: 03/28/2019 Patient Sequence Number: 1
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