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 2-D BARCODE READER; SYSTEM/DEVICE, PHARMACY COMPOUNDING
  • 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 2-D BARCODE READER; SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 65000500
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the 2-d barcode reader had microbial growth.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to d9, g3, h3, and h6.H10: the device was received for evaluation.A visual inspection was performed and the scanner housing was found scratched from wear and tear from repeated use as well as an ingredient spill on the scanner.The scanner was plugged into a computer and powered, however it did not scan, nor did it pass scanner tests.Further inspection revealed the unit had rust.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
2-D BARCODE READER
Type of Device
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11608478
MDR Text Key246109966
Report Number1416980-2021-01835
Device Sequence Number1
Product Code NEP
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/07/2021
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 Other
Device Catalogue Number65000500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
Initial Date Manufacturer Received 03/10/2021
Initial Date FDA Received04/02/2021
Supplement Dates Manufacturer Received05/04/2021
Supplement Dates FDA Received05/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-