• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. STIMUQUIK: 21G X 9CM (3.5") PNB NEEDLE ANESTHESIA CONDUCTION KIT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTIMUQUIK: 21G X 9CM (3.5") PNB NEEDLE
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11015605
MDR Text Key227723189
Report Number1036844-2020-00331
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
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 Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAB-21090-SS
Device Lot Number18E16-1-P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2021
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

-
-