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

Catalog Number AB-21090-SS

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

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

The customer states that the item leaked during a procedure but that the patient was not harmed.Additional information: during a pain block that was being done at our facility product ab-21090-ss leaked during the procedure.The lot number is 18e16-1-p.There was not any injury or death to the patient.Another needle was used and work without any issues.

Event Description

The customer states that the item leaked during a procedure but that the patient was not harmed.Additional information: during a pain block that was being done at our facility product ab-21090-ss leaked during the procedure.The lot number is 18e16-1-p.There was not any injury or death to the patient.Another needle was used and work without any issues.

Manufacturer Narrative

(b)(4).A device history record was not available for review.The customer reported a leak during use of the stimuquik needle.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 stimuquik leaking was confirmed based on the sample received.During visual inspection, a crack was observed in the tubing at the hub connection of the needle.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.

• Brand Name: STIMUQUIK: 21G X 9CM (3.5") PNB NEEDLE
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11015605
• MDR Text Key: 227723189
• Report Number: 1036844-2020-00331
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K173321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2023
• Device Catalogue Number: AB-21090-SS
• Device Lot Number: 18E16-1-P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1