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: BAXTER HEALTHCARE - CARTAGO CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION
  • 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
 

BAXTER HEALTHCARE - CARTAGO CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number 4C8723
Medical Device Problem Code Disconnection (1171)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
This report summarizes 1 malfunction events.It was reported that the tubing of a clearlink y-type blood/solution set was detached from the distal end of the y-site.This occurred during an unknown process step.It was not specified whether there was patient involvement.No additional information is available.
 
Additional Manufacturer Narrative
Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CLEARLINK BLOOD RECIPIENT SET
Common Device Name
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER HEALTHCARE - CARTAGO
cartago
MDR Report Key8832416
Report Number1416980-2019-04061
Device Sequence Number19466491
Product Code BRZ
UDI-Device Identifier00085412049076
UDI-Public(01)00085412049076
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/18/2019
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? No
Operator of Device No Information
Device Catalogue Number4C8723
Device Lot NumberR18I13095
Initial Date Received by Manufacturer 06/30/2019
Supplement Date Received by Manufacturer09/30/2019
Initial Report FDA Received Date07/26/2019
Supplement Report FDA Received Date10/18/2019
Patient Sequence Number1
-
-