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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ARROW; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number EJ-05400-E
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2015
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 that the device leaked.The catheter was removed and a new catheter was inserted without issue.No patient injury reported.
 
Manufacturer Narrative
(b)(4).The customer returned one epidural catheter, one snaplock adapter with clip, and one flat filter.A visual exam was performed on the filter and it was observed that the filter had tooling marks in the female luer.No other defects were observed.No issues were found with the snaplock adapter; however, the catheter appeared to be used as adhesive residue was present on the catheter body exterior.A small cut in the extrusion could be seen near offset coils approx 40cm from the distal end.No other defects were observed.Functional testing was performed and a leak could be seen immediately from the location of the offset coils in the catheter.No other leaks were detected.The test was repeated with the returned snaplock adapter and a lab inventory epidural catheter.No leaks were detected indicating that there are no functional problems with the returned snaplock adapter.A manual leak test was performed with the returned flat filter and no leaks were detected.A dhr review was performed on the epidural catheter and snaplock adapter with no relevant findings.The reported complaint of a leak from the connector was not confirmed based on the returned sample.The components were submitted to leak testing and neither the snaplock adapter, nor the flat filter other remarks: returned were found to leak.The returned catheter was found to leak as a result of a small cut in the extrusion located near offset coils.A dhr review was performed on the epidural catheter and snaplock adapter with no evidence to suggest a manufacturing related cause.Therefore, based on the damage observed and the time of discovery, it was determined that operational context caused or contributed to this event.
 
Event Description
The customer alleges that the device leaked.The catheter was removed and a new catheter was inserted without issue.No patient injury reported.
 
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Brand Name
ARROW
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 Key5219837
MDR Text Key31234146
Report Number3006425876-2015-00342
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
Report Date 11/02/2015
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 No Information
Device Expiration Date05/31/2016
Device Catalogue NumberEJ-05400-E
Device Lot Number71F14L1080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/02/2015
Initial Date FDA Received11/12/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/21/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2014
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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