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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET: 19 GA ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET: 19 GA ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number EC-05400-E
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device investigation report has not been submitted at this time. The manufacturer will continue to monitor and trend related events.
 
Event Description
After locking the snaplock adapter, it gradually loosed and resulted in catheter shedding. The catheter could not be secured and was released from the snaplock. 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 that the snaplock adapter became loosened from the catheter. The customer returned one snaplock adapter, one flat filter, and one epidural catheter ((b)(4)). The returned components were received connected together. The returned components were visually examined with and without magnification. The snaplock adapter appears typical with no defects or anomalies observed. The flat filter appears typical with no defects or anomalies observed. Visual examination of the returned epidural catheter revealed that the catheter appears used. Biological material can be seen between the catheter coils and adhesive residue is present on the catheter body exterior. No other defects or anomalies were observed. The customer also returned a photo of the epidural catheter and snaplock adapter in a biohazard bag. The snaplock adapter is taped around its closure point. No other defects or anomalies were observed. Other remarks: a functional leak test was performed on the returned sample per mrq 000017 section 6. 5; rev. 5. The returned epidural catheter was inserted from the proximal end into the returned snaplock adapter until it bottomed out and the snaplock adapter was closed. The components were confirmed to be secured by tugging gently. The snaplock adapter was connected to the lab leak tester ((b)(4)) and the pressure was increased to 10 psi to establish flow. The distal end of the catheter was capped off and the pressure was increased to 25 psi for 30 seconds. No leaks were detected and the components remained secured. A functional spo test was then performed per mrq 000017 section 6. 7; rev 5. The proximal end of the epidural catheter was re-inserted into the snaplock adapter until it bottomed out and the snaplock adapter was locked. The components were confirmed to be secured by tugging gently on the catheter. The components were then left to sit for 72 hours in the locked position. After 72 hours, the snaplock adapter was confirmed to have remained securely locked with the catheter inserted. No functional issues were found ((b)(4)). No corrective action needed at this time since no functional issues were found with the returned snaplock adapter. The reported complaint of the snaplock adapter loosened from the catheter could not be confirmed through functional testing of the returned snaplock adapter. The snaplock adapter was secured to the epidural catheter and passed the functional tests performed including a spontaneous partial opening (spo) test. There was no problem found with the returned snaplock adapter.
 
Event Description
After locking the snaplock adapter, it gradually loosed and resulted in catheter shedding. The catheter could not be secured and was released from the snaplock. The catheter was replaced. The patient's condition was reported as fine.
 
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Brand NameEPIDURAL CATHETERIZATION SET: 19 GA
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 Key5883897
MDR Text Key52388845
Report Number3006425876-2016-00237
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeTW
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 07/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Catalogue NumberEC-05400-E
Device Lot Number71F15K1870
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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