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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (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 was pierced at its end.An epidural catheter was needed for a female patient in pain.A leak was detected from the catheter.Usage was stopped and the catheter was replaced.
 
Event Description
It was reported that the epidural catheter was pierced at its end.A epidural catheter was needed for a female patient in pain.A leak was detected from the catheter.Usage was stopped and the catheter was replaced.
 
Manufacturer Narrative
(b)(4).A device history record review was performed and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit (e-17019-110a rev 02) contains warnings and techniques to mitigate damage to the catheter.It states: "do not alter catheter during insertion, use, or removal." "some disinfectants used at the catheter insertion site contain solvents which can degrade the catheter material." "to reduce risk of shearing catheter, never withdraw catheter back against needle bevel." "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage." a corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without sample.Complaint verification testing could not be performed as a sample was not returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Manufacturer Narrative
(b)(4).The customer returned one catheter piece.The returned catheter piece was visually examined with and without magnification.Visual examination of the returned catheter piece revealed the likely most distal end appears to be missing.At the point of separation, the extrusion is not stretched.The proximal side of the catheter appears to be intact.Damage to the extrusion can be seen on the returned catheter piece.The extrusion appears to have a cut at 11.1cm from the proximal end ((b)(4)).A dimensional inspection was performed on the returned catheter piece using a ruler ((b)(4)).The returned catheter extrusion piece measures approximately 12.8cm.The extrusion does not appear to be stretched at the point of separation.At least 75.7cm of the catheter is missing as the specification for the epidural catheter indicates that the proper length of an epidural catheter is 88.5-91.5 cm per graphic (b)(4).A functional leak test was performed per (b)(4) using the returned catheter piece and a lab inventory snaplock adapter with the lab leak tester (c05176).The proximal end of the catheter piece 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 likely most 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 11.1cm from the proximal end, which was revealed during the visual inspection.No other leaks were detected.Specifications per (b)(4) were reviewed as a part of this complaint investigation.The ifu for this kit, (b)(4), was reviewed as a part of this complaint investigation.The ifu cautions the user, "do not alter the catheter or any other kit/set component during insertion, use or removal (except as instructed)." 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 unintentional user error caused or contributed to this event.The reported complaint of the catheter leaking was confirmed based on the sample received.Although, only 12.8cm of the catheter was returned, the epidural catheter was leak tested and confirmed to leak from where the catheter was damaged at approximately 11.1cm 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 upon the condition of the sample received, unintentional user error caused or contributed to this event.
 
Event Description
It was reported that the epidural catheter was pierced at its end.A epidural catheter was needed for a female patient in pain.A leak was detected from the catheter.Usage was stopped and the catheter was replaced.
 
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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 Key8046408
MDR Text Key126408755
Report Number3006425876-2018-00729
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,Followup
Report Date 08/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/17/2020
Device Catalogue NumberJC-05400-B
Device Lot Number71F18F1548
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2019
Date Manufacturer Received02/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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