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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number ASK-05500-KM
Device Problems Leak/Splash (1354); Cut In Material (2454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/17/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been returned for investigation at this time. The manufacturer will continue to monitor and trend related events.
 
Event Description
Alleged event: the user found a solution leaking from the catheter. The user stopped using it because a crack was found on the catheter. As a result the catheter was replaced by a new one. The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4). The customer reported the catheter was leaking. The customer returned one snaplock adapter with clamp, one flat filter, and one epidural catheter. The components were received connected together (reference files (b)(4). The returned components were visually examined with and without magnification. Visual examination of the returned filter revealed that the filter appears typical with no observed defects or anomalies. Visual examination of the returned snaplock adapter revealed that the snaplock adapter appears typical with no observed defects or anomalies. Visual examination of the returned epidural catheter revealed that the catheter is used as adhesive material can be seen on the outer extrusion. The coils appear to be offset at approximately 22cm (ruler (b)(4)) from the distal. No other defects or anomalies were observed. A functional leak test was performed per mrq 000017 section 6. 5; rev 5 using the returned catheter and the returned snaplock adapter. The returned catheter was inserted into the snaplock adapter until it bottomed out and the components were then connected to the lab leak tester ((b)(4)). The pressure was set at 10 psi to establish flow. The catheter was found to leak immediately at approximately 22cm from other remarks: the distal end. This is the location where the coils were offset. Microscopic examination revealed a cut of the extrusion was observed at the same location. The distal end of the catheter was capped off and the pressure was increased to 25 psi for 30 seconds. No additional leaks were detected. A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause. All epidural catheters are tested for leaks at the time of manufacturing. A device history record review performed on the epidural catheter showed no evidence to suggest a manufacturing related cause. The leak was detected during use. Therefore, based on the condition of the sample received and the time of discovery indicate operational context caused or contributed to this event.
 
Event Description
Alleged event: the user found a solution leaking from the catheter. The user stopped using it because a crack was found on the catheter. As a result the catheter was replaced by a new one. The patient's condition was reported as fine.
 
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Brand NameEPIDURAL 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
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key5531820
MDR Text Key41411673
Report Number3006425876-2016-00067
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
Type of Report Initial,Followup
Report Date 03/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2017
Device Catalogue NumberASK-05500-KM
Device Lot Number71F15E1564
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/28/2015
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: 03/29/2016 Patient Sequence Number: 1
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