MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ INOCULUM BROTH 2.2 ML; SEE H.10

Model Number	246005
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(4).Common device name: culture media, non-selective and non-differential 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 bd phoenix¿ inoculum broth 2.2 ml label were missing, the following information was provided by the initial reporter: this is a report about a missing label.The labels on most of all 100 tubes in the carton were found to be missing, wrinkled or torn.
Additional Manufacturer Narrative
H6.Investigation summary: this complaint is not confirmed.This complaint is for damaged and missing tube labels of phoenix inoculum broth (246005) batch number 2188117.The customer did not provide photos or product returns for investigation.To investigate, retention samples of the complaint batch were inspected, which revealed no defects.As a result, this complaint is unconfirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints was performed and revealed two (2) additional complaints on the complaint batch, which were related to this defect.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 or Problem Description
It was reported that bd phoenix¿ inoculum broth 2.2 ml label were missing, the following information was provided by the initial reporter: this is a report about a missing label.The labels on most of all 100 tubes in the carton were found to be missing, wrinkled or torn.

• Brand Name: BD PHOENIX¿ INOCULUM BROTH 2.2 ML
• Common Device Name: 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: 16277509
• Report Number: 1119779-2023-00090
• Device Sequence Number: 12510754
• Product Code: JSG
• UDI-Device Identifier: 30382902460054
• UDI-Public: 30382902460054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• 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): 02/16/2023

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
• Operator of Device: Other
• Device Expiration Date: 07/01/2023
• Device Model Number: 246005
• Device Catalogue Number: 246005
• Device Lot Number: 2188117
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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