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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 Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/04/2018
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 catheter came off the snaplock adaptor during use on a patient.The medical agent was found leaking from the adapter and the catheter came off.The catheter was removed and replaced.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.The customer reported that the snaplock assembly disconnected from the catheter.The customer returned one snaplock assembly, one flat filter, and one epidural catheter (reference attached files (b)(4).The returned components were visually examined with and without magnification.The snaplock assembly 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.A functional leak test was performed on the returned sample per amrq- 000017 section 7.5; rev.7.The returned epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly 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 spontaneous partial opening (spo) test was then performed per amrq-000017 section 7.7; rev 7.The proximal end of the epidural catheter was re-inserted into the snaplock assembly until it bottomed out and the snaplock assembly 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 assembly was confirmed to have remained securely locked with the catheter inserted.No functional issues were found.No corrective action needed at this time since no functional issues were found with the returned snaplock assembly.The reported complaint of the snaplock assembly disconnecting from the catheter could not be confirmed through functional testing of the returned snaplock assembly.The snaplock assembly 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 assembly.
 
Event Description
It was reported that the catheter came off the snaplock adaptor during use on a patient.The medical agent was found leaking from the adapter and the catheter came off.The catheter was removed and replaced.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8005079
MDR Text Key125012557
Report Number3006425876-2018-00708
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2019
Device Catalogue NumberASK-05500-KM
Device Lot Number71F18C2300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2018
Date Manufacturer Received11/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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