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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SETS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JH-05500
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Date 01/05/2018
Event Type  malfunction  
Event Description
It was reported that the epidural catheter broke off hours after insertion. The patient complained of level 10 pains. The anesthesiologist was called to assist and found the end of catheter that was inserted into patient had broken off and was found on the floor. There was no patient injury.
 
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, e-17019-109a; rev. 5, 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. " 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 catheter with no evidence to indicate a manufacturing related issue. Therefore, the potential cause of the catheter breaking could not be determined based upon the information provided and without the sample.
 
Manufacturer Narrative
(b)(4). The device has not been returned for investigation at this time. Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the epidural catheter broke off hours after insertion. The patient complained of level 10 pains. The anesthesiologist was called to assist and found the end of catheter that was inserted into patient had broken off and was found on the floor. There was no patient injury.
 
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Brand NameEPIDURAL CATHETERIZATION SETS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7221215
MDR Text Key280779635
Report Number3003737899-2018-00006
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberJH-05500
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

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