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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ARROW EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JC-05400-B
Device Problem Partial Blockage (1065)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 11/04/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).It is unknown if the device sample is available for evaluation.
 
Event Description
The customer alleges that the catheter was blocked.The issue was noted prior to use.No patient injury reported.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record (dhr) review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.The potential cause of a blocked catheter could not be determined based upon the information provided and without a sample.If the sample is returned, a follow-up report will be submitted with investigation results.
 
Event Description
The customer alleges that the catheter was blocked.The issue was noted prior to use.No patient injury reported.
 
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Brand Name
ARROW EPIDURAL CATHETERIZATION SET
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 Key5219777
MDR Text Key30983191
Report Number3006425876-2015-00345
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 11/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2017
Device Catalogue NumberJC-05400-B
Device Lot Number71F15H1188
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/06/2015
Initial Date FDA Received11/12/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2015
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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