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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number AK-05560
Device Problems Break (1069); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2016
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
An epidural catheter was placed into laboring patient without issues but it was difficult to remove at the end. The internal wire broke or unraveled at approximately the 9cm mark when removal was attempted. The catheter was surgically removed. The patient's condition was reported as fine.
 
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 catheter with no relevant findings. The ifu for this kit, (b)(4); rev. 7, 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 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 catheter with no evidence to suggest a manufacturing related cause. The potential cause of the catheter breaking during removal could not be determined based upon the information provided and without a sample.
 
Event Description
An epidural catheter was placed into laboring patient without issues but it was difficult to remove at the end. The internal wire broke or unraveled at approximately the 9cm mark when removal was attempted. The catheter was surgically removed. The patient's condition was reported as fine.
 
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Brand NameSPINAL ANES/EPIDURAL CATH 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 Key6037561
MDR Text Key57797990
Report Number1036844-2016-00523
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 09/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberAK-05560
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 Received11/16/2016
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: 10/18/2016 Patient Sequence Number: 1
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