Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SAFETY NEEDLE 21 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN
  • 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
 

COVIDIEN SAFETY NEEDLE 21 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number 8881850110
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/24/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event or Problem Description
The customer reported that the device is pulling in air/bubbles when drawing blood.Additional information received stated this has happened sporadically over the past months.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SAFETY NEEDLE 21 X 1
Common Device Name
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
COVIDIEN
2010 east international speedw
deland FL 32724
MDR Report Key9290150
Report Number1017768-2019-00726
Device Sequence Number19410986
Product Code FMI
UDI-Device Identifier10884521000513
UDI-Public10884521000513
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number8881850110
Device Catalogue Number8881850110
Device Lot Number900742
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/24/2019
Initial Report FDA Received Date11/07/2019
Patient Sequence Number1
-
-