MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ ID BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number	246001
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that while using the bd phoenix¿ id broth that there was a bottle without a label.The following information was provided by the initial reporter: the client indicated that he found a bottle without a label, and another bottle with a half-open lid.It looked cloudy against the light.And when you make a plaque he told them that it is contaminated.
Additional Manufacturer Narrative
H.6 investigation summary: this complaint is confirmed.This complaint is for various physical defects of phoenix id broth (246001) batch number 1287552, including unlabeled tube, low fill and contamination.The photos illustrated a tube of that was empty, a tube that did not contain a label and a growth on a plate.Based off the photos, this complaint is 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.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 the bd phoenix¿ id broth that there was a bottle without a label.The following information was provided by the initial reporter: the client indicated that he found a bottle without a label, and another bottle with a half-open lid.It looked cloudy against the light.And when you make a plaque he told them that it is contaminated.

• Brand Name: BD PHOENIX¿ ID BROTH
• Common Device Name: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• 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: 15873382
• Report Number: 1119779-2022-01422
• Device Sequence Number: 12124000
• Product Code: JSG
• UDI-Device Identifier: 30382902460016
• UDI-Public: 30382902460016
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: EXEMPT
• 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): 11/29/2022

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: 10/08/2022
• Device Model Number: 246001
• Device Catalogue Number: 246001
• Device Lot Number: 1287552
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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