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 Fluid 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.

• 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: 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

0 Patients were 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

• 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

Was the Report Sent to FDA?

• Event Location: No Information
• 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