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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 Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue ot monitor and trend related events.
 
Event Description
It was reported that during insertion of the epidural catheter, the plunger of the syringe slid down (self-expelled) while purging the air.The syringe had been filled with nacl 0.9%.It happened few times.There was no consequence for the patient; another device was used.
 
Event Description
It was reported that during insertion of the epidural catheter, the plunger of the syringe slid down (self-expelled) while purging the air.The syringe had been filled with nacl 0.9%.It happened few times.There was no consequence for the patient; another device was used.
 
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 empty kit with a 10ml plastic lor syringe (reference files (b)(4)).The syringe was visually examined with and without magnification.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.Functional testing was performed on the returned syringe using the lab leak tester (c05176) per the parameters in (b)(4), section 7.2-positive pressure leakage.Water was aspirated into the syringe to the 8ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.No leaks were detected.The plunger was rotated 45deg and the syringe was once again tested at 10psi for 10 seconds and no leaks were detected.This was performed by rotating the plunger 45deg until the plunger had rotated a full 360deg with no leaks detected.It should be noted, water could be seen on the blue stopper between the seals (reference files (b)(4)).However, this is not considered a leak based on the current test method.Water was removed from the syringe to the 2ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.No leaks were detected.This was performed by rotating the plunger 45deg until the plunger had rotated a full 360deg with no leaks detected.The returned lor syringe was compared to a lab inventory syringe by sliding the plunger into the barrel of the syringe.The resistance of the returned lor syringe was comparable to the lab inventory syringe.The luer end of the returned syringe was capped with the plunger completely inserted.An attempt to remove the plunger from the barrel was performed.The plunger seal snapped back when attempting to remove from the barrel.This was also performed with a lab inventory syringe with the same results.This indicates the plunger seal was creating a vacuum with no issues.The luer end of the returned syringe was capped.With the tip sealed, the lor syringe was tested for leaks by pushing the plunger into the barrel.This was performed at 8ml, 5ml, and 2ml by pushing the plunger and rotating 45deg until the plunger had rotated a full 360deg.No leaks or slippage of the plunger occurred.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per eco-051699 (released 03-dec-2018), supplier ((b)(4)) made the following changes: kz-05501-002 luer plastic lor syringe: changed plunger material from (b)(4) 535 to (b)(4) 531.Changed to new plunger tool.Changed to new mold for blue stopper.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.Although, no leaking issues were found with the returned lor syringe based on the current test method, due to the recent increase in volume for this complaint issue, teleflex has reached out to the supplier for further assistance to help investigate this complaint issue.The reported complaint of the lor syringe leaking could not be confirmed based on the sample received.The returned lor syringe passed functional testing including a leak test.Also, the returned lor syringe when compared to a lab inventory syringe had comparable resistance when sliding the plunger into the barrel of the syringe.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.Although, no leaking issues were found with the returned lor syringe, based on the recent increase in volume for this complaint issue, teleflex has reached out to the supplier for further assistance to help investigate this complaint 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 Key9261698
MDR Text Key167008166
Report Number3006425876-2019-00822
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 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/19/2021
Device Catalogue NumberJC-05400-B
Device Lot Number71F19G2837
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Date Manufacturer Received11/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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