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; SET, ADMINISTRATION, INTRAVASCULAR
  • 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; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number ASKU
Device Problems Crack (1135); Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 01/03/2021
Event Type  malfunction  
Manufacturer Narrative
The device was discarded and the lot is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an unspecified iv (intravenous) double spike infusion set leaked due to a hairline fracture in the base of the set.The device was primed with finomel and a bag of dextrose saline.This was identified prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was received which confirmed, that the device involved in this report was a non-baxter product.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NI
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11306632
MDR Text Key232210159
Report Number1416980-2021-00505
Device Sequence Number1
Product Code FPA
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,foreig
Type of Report Initial,Followup
Report Date 02/15/2021
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
Device Operator Health Professional
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/15/2021
Initial Date FDA Received02/10/2021
Supplement Dates Manufacturer Received02/10/2021
Supplement Dates FDA Received02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-