MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. STIMUQUIK: 21G X 9CM (3.5") PNB NEEDLE; ANESTHESIA CONDUCTION KIT

Catalog Number AB-21090-SS

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2018

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 there was a hole in the tubing near the hub of the needle which caused air to be aspirated and fluid spraying out during the nerve block on the patient.This was discovered after the needle was already in the patient's skin.There was no patient injury.

Event Description

It was reported that there was a hole in the tubing near the hub of the needle which caused air to be aspirated and fluid spraying out during the nerve block on the patient.This was discovered after the needle was already in the patient's skin.There was no patient injury.

Manufacturer Narrative

Qn#(b)(4).A device history record was not available for review.The customer reported a leak could be seen coming from the tubing connected to the hub of the stimuquik needle.The customer returned one stimuquik needle and packaging (reference attached files inp20028918).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.A device history record was not available for review.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 filter leaking could not be determined.

• Brand Name: STIMUQUIK: 21G X 9CM (3.5") PNB NEEDLE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8146153
• MDR Text Key: 129891402
• Report Number: 3011137372-2018-00315
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K014246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB-21090-SS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1