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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JC-05400-B
Device Problem Fluid/Blood Leak (1250)
Patient Problems Cerebrospinal Fluid Leakage (1772); No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
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 between (b)(6) 2019 and (b)(6) 2019, few issues happened.While filling the syringe, the anesthetists observed that the plunger goes up by itself.It caused liquid leaks and air leaks.This occurred between the time of insertion and while in use with some resistance regained after a while.Doctors have also had issues when they are looking for the epidural space (loss of resistance).5 patients suffered from breach dura-mater, 3 had a blood patch.
 
Event Description
It was reported that between (b)(6) 2019 and (b)(6) 2019, few issues happened.While filling the syringe, the anesthetists observed that the plunger goes up by itself.It caused liquid leaks and air leaks.This occurred between the time of insertion and while in use with some resistance regained after a while.Doctors have also had issues when they are looking for the epidural space (loss of resistance).5 patients suffered from breach dura-mater, 3 had a blood patch.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported the lor syringe leaked.The customer returned one 10ml plastic lor syringe (reference files (b)(4)) the syringe was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.The returned sample was returned to the supplier (preox) for function testing.According to the supplier, "leakage found by normal handling, manipulation of plunger increases leakage".A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per (b)(4)(released 03-dec-2018), supplier ((b)(4)) made the following changes: kz-05501-002 luer plastic lor syringe: a.Changed plunger material from profax 535 to profax 531 b.Changed to new plunger tool c.Changed to new mold for blue stopper d.Changed molding location for the plunger and the blue stopper as follows.- plunger: from fleimaplastic in germany to gpe, germany - blue stopper: from et, germany to psilkon, germany these effective changes did impact product design and material.It should be noted, the returned lor syringe was from the new design.The reported complaint of the lor syringe leaking was confirmed based on the sample received.The returned lor syringe was returned to the supplier (preox) for functional testing where according to the supplier, "leakage found by normal handling, manipulation of plunger increases leakage".A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.However, based on the functional testing by the supplier, the potential root cause of this issue is supplier related.A scar has been initiated to further investigate this issue.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9304404
MDR Text Key166951616
Report Number3006425876-2019-00867
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/09/2021
Device Catalogue NumberJC-05400-B
Device Lot Number71F19F1426
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Date Manufacturer Received12/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
N/A.
Patient Outcome(s) Required Intervention;
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