MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST-S BROTH; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number	246007
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone (b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd phoenix¿ ast-s broth turbidity was found in one of the culture tubes which was suspected to have been contaminated during production or transportation.No patient impact.The following information was provided by the initial reporter: the customer found turbidity in one of the culture tubes when using the culture medium of this batch number, which was suspected to have been contaminated during production or transportation.The client hopes to find out the reason as soon as possible and give her a reply.
Additional Manufacturer Narrative
H.6 investigation summary: this complaint is confirmed.This complaint is for foreign matter seen within tubes of phoenix ast-s broth (246007) batch number 2089921.The customer did provide photos for investigation, but no product returns.The photos illustrated foreign material within broth tubes.Based off the photos, this complaint is confirmed.A review of quality notifications revealed one quality notification generated on the complaint batch, not related to this defect.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.Please continue to communicate additional concerns.Per baltrmphxidastaph rev 10 version h, id 15.0, a defective product obvious to user has a severity assessment of s1.Per baltms0184 ver k a complaint with a severity ranking of s1 or s2 may require investigational testing, including retain sample analysis.However, the customer returned photos which were used for the investigation; therefore, a review of retention samples is not required.
Event or Problem Description
It was reported that while using bd phoenix¿ ast-s broth turbidity was found in one of the culture tubes which was suspected to have been contaminated during production or transportation.No patient impact.The following information was provided by the initial reporter: the customer found turbidity in one of the culture tubes when using the culture medium of this batch number, which was suspected to have been contaminated during production or transportation.The client hopes to find out the reason as soon as possible and give her a reply.

• Brand Name: BD PHOENIX¿ AST-S BROTH
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• 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: 15322902
• Report Number: 1119779-2022-01150
• Device Sequence Number: 5505699
• Product Code: LON
• UDI-Device Identifier: 30382902460078
• UDI-Public: 30382902460078
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2022

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
• Operator of Device: Other
• Device Expiration Date: 10/07/2022
• Device Model Number: 246007
• Device Catalogue Number: 246007
• Device Lot Number: 2089921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown