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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JC-05400-E
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has been returned but the investigation report has not been submitted at this time. The manufacturer will continue to monitor and trend related events.
 
Event Description
Reported event: it was reported that the connector loosens time after time at the catheter end. The catheter was replaced. The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the epidural catheter and snaplock adapter with no relevant findings. The customer reported the catheter disconnected from the snaplock adapter. The customer returned one snaplock adapter, one flat filter, and a piece of an epidural catheter approximately 8. 5cm (reference files (b)(4)). The components were received connected together and no snaplock clip was returned. The components were visually examined with and without magnification. Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies. Visual examination of the returned flat filter revealed that the flat filter appears typical with no observed defects or anomalies. A functional leak test was performed per mrq 000017 section 6. 5 rev. 5 using a lab inventory catheter and the returned snaplock adapter. The proximal end of the epidural catheter was inserted into the snaplock adapter until it bottomed out and the snaplock was closed. The components were confirmed to be secured by tugging gently on the catheter. The snaplock adapter was then connected to the lab leak other remarks: tester (c05176) and the pressure was increased to 10 psi to establish flow. The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds. No leaks were detected. A second functional test was performed using the returned components per mrq 000017 section 6. 7 rev. 5 spontaneous partial opening. The catheter was confirmed to be secured in the snaplock adapter and then the components were left to sit for 72 hours in the closed position. After 72 hours, the snaplock adapter was examined and confirmed to remain in the closed position with the catheter secure. No functional issues were found with the snaplock adapter. A corrective action is not required at this time as there were no functional issues found with the returned sample. The reported complaint of a disconnect between the snaplock adapter and the epidural catheter could not be confirmed based upon the sample received. The returned components passed all functional testing including a spontaneous partial opening test. A device history record review was performed on the epidural catheter and snaplock adapter with no evidence to suggest a manufacturing related cause. There were no functional issues found with the returned sample.
 
Event Description
Reported event: it was reported that the connector loosens time after time at the catheter end. The catheter was replaced. The patient's condition was reported as fine.
 
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Brand NameEPIDURAL CATHETERIZATION SET
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
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key5643030
MDR Text Key44891406
Report Number3006425876-2016-00106
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeNL
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 04/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2017
Device Catalogue NumberJC-05400-E
Device Lot Number71F15G1079
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/20/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/10/2016 Patient Sequence Number: 1
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