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	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd phoenix¿ id broth labels were missing.The following information was provided by the initial reporter: "this is a report about missing labels.According to the customer's report, there were 2 tubes without labels.".
Additional Manufacturer Narrative
Device evaluated by mfr: 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¿ id broth labels were missing.The following information was provided by the initial reporter: "this is a report about missing labels.According to the customer's report, there were 2 tubes without labels.".
Additional Manufacturer Narrative
H.6 investigation summary: this complaint is not confirmed.This complaint is for missing labels on tubes of phoenix id broth (246001) batch number 2132650.The customer did not provide photos or product returns for investigation.To investigate, the retention box of the complaint batch was visually and manually inspected for the presence of labels on tubes.The inspection revealed 0/100 tubes with defects in labeling.Based off the investigation, this complaint is not confirmed.A review of quality notifications revealed no quality notification 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.

• 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: 15675529
• Report Number: 1119779-2022-01330
• Device Sequence Number: 6407058
• Product Code: JSG
• UDI-Device Identifier: 30382902460016
• UDI-Public: 30382902460016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: 05/06/2023
• Device Model Number: 246001
• Device Catalogue Number: 246001
• Device Lot Number: 2132650
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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