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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 FR-05501-10
Device Problem Failure to Advance (2524)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 01/09/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It is unknown if the device sample is available for evaluation.
 
Event Description
The customer alleges that it was impossible to introduce the catheter inside the needle; the catheter was stuck at the entrance of the needle.
 
Manufacturer Narrative
Qn#(b)(4). The customer returned one sealed kit from the same lot number for evaluation. The kit was opened and the epidural needle and epidural catheter were removed. The components were visually examined and no defects or anomalies were observed. A dimensional inspection was performed on the returned epidural needle and it was found to be within specification. Functional testing was also performed and there were no issues found. A device history record (dhr) review was performed on the epidural needle and epidural catheter with no relevant findings. The reported complaint of difficulty threading the epidural catheter through the needle could not be confirmed based on the sample received. The actual complaint sample was not returned; only a representative sample was received. The returned epidural catheter could be threaded through the returned needle with no resistance met. The returned components passed a functional drag test, and the returned needle id and returned catheter od were found to be within specification. A dhr review was performed on the epidural needle and catheter with no evidence to suggest a manufacturing related cause. A potential root cause could not be determined based upon the information provided or without the actual complaint sample.
 
Event Description
The customer alleges that it was impossible to introduce the catheter inside the needle; the catheter was stuck at the entrance of the needle.
 
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Brand NameARROW EPIDURAL CATHETERIZATION KIT
Type of DeviceANESTHESIA 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 Key5391516
MDR Text Key36849812
Report Number3006425876-2016-00011
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Catalogue NumberFR-05501-10
Device Lot Number71F15J1926
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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