• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST INDICATOR SOLUTION; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY

  • 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
 

BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST INDICATOR SOLUTION; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY Back to Search Results
Model Number 246004
Device Problem Expiration Date Error (2528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that while using bd phoenix¿ ast indicator solution incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the outer box and inner packaging date are different.".
 
Manufacturer Narrative
H6: investigation summary: this complaint is for the incorrect expiration date on the foil pouch of phoenix ast indicator (246004) batch 1105781.The customer did return multiple photos which showed the pouch with a date of 04-30-2020 when the correct expiration date is 04-30-2022.The photos also showed the bottle which displayed the correct expiration date of 04-30-2022.To investigate further the expiration date was verified along with manufacture date.It was determined that the expiration of 04-30-2022 was the correct date of expiration and that the product was useable.Based on the photos provided this complaint is confirmed.A review of quality notifications revealed one quality notification generated on the complaint batch, qn (b)(4).A review of complaints was performed and there were fifteen additional complaints filed for this batch not all for the same defect.A complaint trend was identified for this defect.Based on the severity and rate, a corrective and preventive action (capa) investigation was not initiated.H3 other text : see h10.
 
Event Description
It was reported that while using bd phoenix¿ ast indicator solution incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the outer box and inner packaging date are different.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD PHOENIX¿ AST INDICATOR SOLUTION
Type of Device
SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer (Section G)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12305322
MDR Text Key266014841
Report Number1119779-2021-01346
Device Sequence Number1
Product Code LON
UDI-Device Identifier30382902460047
UDI-Public30382902460047
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K020321
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/02/2021
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 Expiration Date04/30/2022
Device Model Number246004
Device Catalogue Number246004
Device Lot Number1105781
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/16/2021
Initial Date FDA Received08/10/2021
Supplement Dates Manufacturer Received12/02/2021
Supplement Dates FDA Received12/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-