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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET: 19 GA; CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET: 19 GA; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number EC-05400-E
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/27/2018
Event Type  Injury  
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 epidural catheter placement was difficult but atraumatic.The catheter was unable to be injected.After assessing the situation, troubleshooting both the process and equipment as well as manipulating the catheter it was removed.A second catheter was placed and injected normally.Post care the first catheter was reviewed.After multiple high pressure attempts to inject the catheter a small piece of string like plastic material came from the distal opening of the catheter.There were no kinks cuts or other visible disruptions to the catheter.There was no patient injury.
 
Event Description
It was reported that the epidural catheter placement was difficult but atraumatic.The catheter was unable to be injected.After assessing the situation, troubleshooting both the process and equipment as well as manipulating the catheter it was removed.A second catheter was placed and injected normally.Post care the first catheter was reviewed.After multiple high pressure attempts to inject the catheter a small piece of string like plastic material came from the distal opening of the catheter.There were no kinks cuts or other visible disruptions to the catheter.There was no patient injury.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.The potential cause of the catheter being blocked could not be determined based upon the information provided and without a sample.
 
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Brand Name
EPIDURAL CATHETERIZATION SET: 19 GA
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7713766
MDR Text Key114826263
Report Number3006425876-2018-00513
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,health
Type of Report Initial,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Catalogue NumberEC-05400-E
Device Lot Number14F18D0261
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/17/2018
Initial Date FDA Received07/24/2018
Supplement Dates Manufacturer Received09/04/2018
Supplement Dates FDA Received09/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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