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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION COMPONENT; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION COMPONENT; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number MP-00019-S
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the user tried to tighten the cap of snaplock adaptor, but he could not.It was reported that only the snaplock adaptor was replaced by a new one at first, but it has been confirmed that catheter was also removed and replaced a new one.There was no reported patient injury.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the snaplock adapter with no relevant findings.Functional testing was performed on the returned sample.The returned snaplock adapter was functionally tested by screwing the dust cap on and off the snaplock adapter.The dust cap fit typically onto the snaplock adapter with no issues.A functional leak test was performed on the returned sample per mrq 000017 section 7.5; rev.7.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 (c05176) 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 7.7; rev 7.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 other remarks: 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 (reference files (b)(4).The reported complaint of the snaplock adapter cap not tightening correctly could not be confirmed through functional testing of the returned snaplock adapter.The dust cap could be screwed on and off typically with no issues.Also, 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
It was reported that the user tried to tighten the cap of snaplock adaptor, but he could not.It was reported that only the snaplock adaptor was replaced by a new one at first, but it has been confirmed that catheter was also removed and replaced a new one.There was no reported patient injury.
 
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Brand Name
EPIDURAL CATHETERIZATION COMPONENT
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
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key7392437
MDR Text Key104253937
Report Number3006425876-2018-00231
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/04/2019
Device Catalogue NumberMP-00019-S
Device Lot Number71F17E2166
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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