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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. STIMUQUIK: 22G X 5CM (2") PNB NEEDLE; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL INC. STIMUQUIK: 22G X 5CM (2") PNB NEEDLE; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number AB-22050-SS
Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/22/2019
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 while using a nerve block needle this morning while performing an interscalene nerve block on a patient it was noticed that there was fluid leaking from the tubing.The needle was immediately removed.A hole was visualized in the tubing at the hub of the needle.The needle and packaging were saved.Another nurse then reported that last week they had to replace a block needle because air was aspirated.They believed there was a hole in that tubing as well.That needle was not saved unfortunately.
 
Manufacturer Narrative
Qn#(b)(4).A device history record was not available for review.The customer reported a leak coming from the needle/tubing.The customer returned one stimuquik needle and packaging.The returned sample was visually examined with and without magnification.The stimuquik needle and cable appear typical; however, microscopic examination of the tubing revealed there is a crack in the tubing near the hub of the needle.A manual leak test was performed on the returned tubing of the needle by plugging the cannula tip and connecting a lab inventory syringe to the luer-lock end of the tubing and manually injecting water.A leak could be seen coming from a crack in the tubing where it connects to the hub of the needle, which was revealed during the visual inspection.No other leaks were detected.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the tubing leaking was confirmed based on the sample received.During the functional inspection, water was observed leaking from the connected tubing at the hub of the needle.It is unknown how the stimucath needle was handled prior to and during use and the pressure used to inject is unknown.Therefore, the potential cause of the tubing leaking could not be determined.
 
Event Description
It was reported that while using a nerve block needle this morning while performing an interscalene nerve block on a patient it was noticed that there was fluid leaking from the tubing.The needle was immediately removed.A hole was visualized in the tubing at the hub of the needle.The needle and packaging were saved.Another nurse then reported that last week they had to replace a block needle because air was aspirated.They believed there was a hole in that tubing as well.That needle was not saved unfortunately.
 
Manufacturer Narrative
Qn#(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint (b)(4) is being reported as a malfunction.There was no serious injury.
 
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Brand Name
STIMUQUIK: 22G X 5CM (2") PNB NEEDLE
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8977291
MDR Text Key156976713
Report Number3011137372-2019-00299
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K173321
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 08/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/26/2024
Device Catalogue NumberAB-22050-SS
Device Lot Number19C26-1-P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2019
Date Manufacturer Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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