MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST BROTH; SEE H.10

Model Number 246003

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

Common device name: system, test, automated antimicrobial susceptibility, short incubation.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd phoenix¿ ast broth that there was incorrect label information.The following information was provided by the initial reporter: customer states that the outer box has the correct cat number of 246003, but the inner box is incorrect with cat number 246007.Customer received the item on november 17, 2022, but opened it (b)(6) 2023.

Manufacturer Narrative

H6.Investigation summary: this complaint is not confirmed.This complaint is for incorrect components in phoenix ast broth (246003) batch number 2243951.The customer did not provide returns but provided photos for the investigation.The photos show a carton of phoenix ast broth (246003) batch number 2243951.Another photo shows tubes of phoenix ast-s broth (246007) batch number 2285304 within the carton.To investigate, retention samples of the complaint batch were manually and visually inspected for incorrect components.Furthermore, review of the batch history record showed 246003 and 246007 were manufactured at different times in different plants.The inspection revealed no defects on the retention samples, therefore this complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints was performed and revealed no additional complaints on the complaint batch.Complaint trending was performed and no trends were identified associated with this defect.A bd id/ast plant quality will continue to monitor for trends associated with this defect.

Event Description

It was reported that while using the bd phoenix¿ ast broth that there was incorrect label information.The following information was provided by the initial reporter: customer states that the outer box has the correct cat number of 246003, but the inner box is incorrect with cat number 246007.Customer received the item on november 17, 2022, but opened it february 8, 2023.

• Brand Name: BD PHOENIX¿ AST BROTH
• Type of Device: SEE H.10
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16362896
• MDR Text Key: 309658316
• Report Number: 1119779-2023-00125
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382902460030
• UDI-Public: 30382902460030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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 Date: 08/29/2023
• Device Model Number: 246003
• Device Catalogue Number: 246003
• Device Lot Number: 2243951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1