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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT Back to Search Results
Catalog Number SJ-05501
Device Problems Hole In Material (1293); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that after successfully placing a technically easy labor epidural, it was noticed that there was significant leaking from the skin insertion site.After troubleshooting the catheter, it was decided to pull it out.The catheter was tested and found a manufacturing hole defect at the 7.8cm mark.Another epidural catheter was placed without problems.There was no patient injury.
 
Event Description
It was reported that after successfully placing a technically easy labor epidural, it was noticed that there was significant leaking from the skin insertion site.After troubleshooting the catheter, it was decided to pull it out.The catheter was tested and found a manufacturing hole defect at the 7.8cm mark.Another epidural catheter was placed without problems.There was no patient injury.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was leaking.The customer returned one 20ml luer-lock syringe, one snaplock adapter, one epidural catheter, and lidstock.The components were received connected together (reference attached files (b)(4)).The returned components were visually examined with and without magnification.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 catheter revealed that the catheter appears used as biological material can be seen on the inner coils.Microscopic examination of the catheter revealed the catheter is damaged at approximately 78mm (c05158) from the distal end.The extrusion appears to have a cut (reference files (b)(4)).No other damage was observed.A functional leak test was performed per mrq 000017 section 7.5 rev.7 using the returned catheter and snaplock adapter with the lab leak tester (c05176).The proximal end of the catheter was inserted into the snaplock adapter until it bottomed out and the components were locked.The catheter was confirmed to be secured by tugging gently.The snaplock adapter was then connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds.A leak was detected coming from the same location where the catheter was cut at 78mm from the distal end, which was revealed during the visual inspection.No other 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.The reported complaint of the catheter leaking was confirmed based on the sample received.The returned epidural catheter was confirmed to leak from where the catheter was damaged at approximately 78mm from the proximal end.All epidural catheters are 100% tested for leaks at the time of manufacturing.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The leak was detected during use.Therefore, based on the time of discovery and the condition of the sample received, operational context caused or contributed to this event.No further action will be taken.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7591209
MDR Text Key111302234
Report Number1036844-2018-00155
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Catalogue NumberSJ-05501
Device Lot Number23F17J0705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2018
Date Manufacturer Received07/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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