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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 AK-05503
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2017
Event Type  malfunction  
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
The report states that they had 3 wet taps due to the catheter and the catheter feels stiffer. The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the epidural catheter and needle with no relevant findings. The customer reported recently three "wet taps" have occurred during insertion of the epidural catheter due to the catheter feeling stiffer. The puncture of the dura or a wet tap is typically a function of the user and is not necessarily a defective component. However, if a component would be involved in the cause it would be the epidural needle which was not returned for evaluation. Therefore, the ifu for this product, e-17019-100d rev. 03, was reviewed as a part of this complaint investigation. The ifu for this product warns the user, "remove needle and attempt new puncture when blood or spinal fluid is returned in plunger barrel. The needle has been placed incorrectly". A review of design change history for part numbers kz-05400-002 and ebz-05400-003 was performed as a part of this investigation. No design changes have been made to this product in the past two years that would have led to this complaint. 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. Other remarks: complaint verification testing could not be performed as no sample was returned for analysis. Typically, a dura puncture or wet tap is a function of the user and is not a function of a defective epidural needle component. A device history record review was performed on the catheter and needle with no evidence to suggest a manufacturing related cause. Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.
 
Event Description
The report states that they had 3 wet taps due to the catheter and the catheter feels stiffer. The patient's condition was reported as fine.
 
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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 Key6573072
MDR Text Key75411280
Report Number1036844-2017-00199
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 05/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2018
Device Catalogue NumberAK-05503
Device Lot Number23F16L0698
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 Received06/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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