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 CORPORATION STERILE LUER LOCK TO URETHERA; DISPENSER, LIQUID MEDICATION
  • 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 CORPORATION STERILE LUER LOCK TO URETHERA; DISPENSER, LIQUID MEDICATION Back to Search Results
Catalog Number H93813501
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This event occurred during the unspecified date of (b)(6) 2020.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that twenty (20) units of luer lock-to-urethral catheter tip adapters leaked between the adapter and catheter.This occurred during infusions with meromyosin and gemcitabine.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information was added to h4 and h6.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were 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
STERILE LUER LOCK TO URETHERA
Type of Device
DISPENSER, LIQUID MEDICATION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10992994
MDR Text Key220969647
Report Number1416980-2020-07710
Device Sequence Number1
Product Code KYX
UDI-Device Identifier00085412478296
UDI-Public(01)00085412478296
Combination Product (y/n)Y
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2022
Device Catalogue NumberH93813501
Device Lot Number60206078
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-