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 3ML SMARTIP MED-PREP CANNULA; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
  • 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 3ML SMARTIP MED-PREP CANNULA; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 8881540133
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/25/2021
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 during use, they noticed contamination on the plastic cannula.There was no patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
3ML SMARTIP MED-PREP CANNULA
Common Device Name
CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COVIDIEN
2010 east international speedw
deland FL 32724
MDR Report Key11253415
Report Number1017768-2021-00901
Device Sequence Number14447382
Product Code GEA
UDI-Device Identifier10884521082946
UDI-Public10884521082946
Combination Product (Y/N)N
Initial Reporter StateID
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/29/2021
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 Number8881540133
Device Catalogue Number8881540133
Device Lot Number033519
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/26/2021
Initial Report FDA Received Date01/29/2021
Patient Sequence Number1
-
-