MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ SENSI-DISC¿ LEVOFLOXACIN - 5 ¿G; SEE H.10

Model Number	231706
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd bbl¿ sensi-disc¿ levofloxacin - 5 gm that there was incorrect label information.The following information was provided by the initial reporter.When staff of storage check product to deliver for customer, they saw information on the label of box not match with content of this box.
Additional Manufacturer Narrative
Common device name: susceptibility test discs, antimicrobial a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary : a complaint investigation due to incorrect label for levofloxacin catalog 231706 batch 2091272 was performed on retention samples.The investigation required to perform visual inspection, and batch record review.No discrepancies observed during the visual inspection.Product was correctly identified.Batch record review did not showed any evidence of customer claim.Photo received from customer was evaluated.It was observed that product was correctly identified.Catalog 231705 and 231706 are correct numbers for levofloxacin (lvx-5) product.Catalog 231706 its for ten pack packaging and catalog 231705 its for single pack packaging.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.
Event or Problem Description
It was reported that while using the bd bbl¿ sensi-disc¿ levofloxacin - 5 ¿gm that there was incorrect label information.The following information was provided by the initial reporter: when staff of storage check product to deliver for customer, they saw information on the label of box not match with content of this box.

• Brand Name: BD BBL¿ SENSI-DISC¿ LEVOFLOXACIN - 5 ¿G
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16550464
• Report Number: 1119779-2023-00290
• Device Sequence Number: 12380041
• Product Code: JTN
• UDI-Device Identifier: 30382902317068
• UDI-Public: 30382902317068
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K970212
• 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): 04/21/2023

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: 04/30/2024
• Device Model Number: 231706
• Device Catalogue Number: 231706
• Device Lot Number: 2091272
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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