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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL INC. ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JH-05500-J
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device sample was not returned for evaluation at the time of this report.
 
Event Description
The customer alleges after insertion of the catheter, the user found the proximal tip of the catheter was deformed.As a result, the catheter was removed and a new catheter was re-inserted.No patient injury reported.
 
Manufacturer Narrative
(b)(4).Visual, functional and dimensional inspection could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as the potential cause of a deformed epidural catheter 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.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.The potential cause of a deformed epidural catheter could not be determined based upon the information provided and without a sample.
 
Event Description
The customer alleges after insertion of the catheter, the user found the proximal tip of the catheter was deformed.As a result, the catheter was removed and a new catheter was re-inserted.No patient injury reported.
 
Manufacturer Narrative
(b)(4).The customer returned one epidural catheter for investigation.The catheter was received in the protective tube assembly.A visual exam was performed and the catheter appeared to be used.The distal tip of the catheter was partially occluded with biological material.No defects were found with the extrusion or coil wire.Visual examination of the proximal end revealed that the extrusion was partially stretched; however, the opening was intact and the assembly of the extrusion over the coil wire was typical.No defects were observed.The returned epidural catheter was functionally tested and no leaks were detected.The reported complaint of a visible defect at the proximal end of the catheter was not confirmed based upon the sample received.The proximal end of the catheter appeared to have a slightly stretched extrusion; however, this anomaly did not affect the functionality of the device and is not considered to be a defect at this time as the catheter could be inserted into a snaplock adapter and passed both a flow and leak test.A dhr review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.
 
Event Description
The customer alleges after insertion of the catheter, the user found the proximal tip of the catheter was deformed.As a result, the catheter was removed and a new catheter was re-inserted.No patient injury reported.
 
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Brand Name
ARROW EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key5258221
MDR Text Key32415851
Report Number3006425876-2015-00352
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date04/30/2017
Device Catalogue NumberJH-05500-J
Device Lot Number71F15E0632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received01/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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