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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number MP-17019-TKL
Device Problem Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been returned for investigation at this time. The manufacturer will continue to monitor and trend related events.
 
Event Description
While attempting to remove the epidural catheter it separated towards the distal end and the wire unraveled. Patient had a ct scan, did not find any metal in the patient's body and could not visualize any catheter fragments. The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4). Visual inspection could not be performed as no sample was returned for analysis. However, the customer did submit a photo. The submitted photo shows a damaged catheter that looks to have separated (reference files (b)(4)). The ifu for this kit, (b)(4), was reviewed as a part of this complaint investigation. The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage. Do not apply additional tension on the catheter if catheter begins to stretch excessively. Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal. During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position. " a corrective action is not required at this time. Although, the customer submitted a photo, a root cause could not be determined based upon the information provided and without a sample. Other remarks: complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed on the catheter with no evidence to suggest a manufacturing related cause. Although, the customer submitted of photo that show a separated catheter, the potential cause of the catheter being difficult to remove could not be determined based upon the information provided and without a sample.
 
Event Description
While attempting to remove the epidural catheter it separated towards the distal end and the wire unraveled. Patient had a ct scan, did not find any metal in the patient's body and could not visualize any catheter fragments. The patient's condition was reported as fine.
 
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Brand NameEPIDURAL CATHETERIZATION KIT: 19 GA
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 carringtin mill blvd
morrisville, NC 27560
9193614124
MDR Report Key5856940
MDR Text Key51481538
Report Number1036844-2016-00424
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
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 07/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2017
Device Catalogue NumberMP-17019-TKL
Device Lot Number23F16C0995
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 Received08/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2016
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: 08/09/2016 Patient Sequence Number: 1
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