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 P400 UM 16FR SIL COUDE CSD IFC; URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER
  • 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 P400 UM 16FR SIL COUDE CSD IFC; URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER Back to Search Results
Model Number P4P16CSDK
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/18/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A representative 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.
 
Event or Problem Description
The customer reported that the foley catheter was disconnected easily.The green seal remained intact but the foley was disconnecting where it connects to the tubing by the sample port.The product was not used on a patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
P400 UM 16FR SIL COUDE CSD IFC
Common Device Name
URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
MDR Report Key10098402
Report Number9612030-2020-02479
Device Sequence Number3406233
Product Code FCN
UDI-Device Identifier10884521174061
UDI-Public10884521174061
Combination Product (Y/N)N
Initial Reporter StateCA
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) 05/28/2020
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 NumberP4P16CSDK
Device Catalogue NumberP4P16CSDK
Device Lot Number1931001864
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/20/2020
Initial Report FDA Received Date05/28/2020
Patient Sequence Number1
-
-