MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ SENSI-DISC¿ CEFTAZIDIME 30 ¿G; SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Catalog Number	231633
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported prior to using the bd bbl¿ sensi-disc¿ ceftazidime 30 ¿g, the user noted that the label of the cartridge containing the product (internal labeling) was different from the shelf package label (external label).No health impact or consequence reported.
Additional Manufacturer Narrative
(b)(6).Investigation summary: a complaint investigation, due to different catalog labeling on the internal packaging on ceftazidime catalog 231633, batch 4156643, was performed.The investigation required to perform visual inspection, photos evaluation and batch record review.No discrepancies observed during the visual inspection.Retention samples were correct and correctly identified (cartridge and box).Returned goods were not received for the investigation.Batch record review did not show any evidence of customer claim.Photo received from customer was evaluated.No discrepancies observed.Product was correct and correctly identified (cartridge and box).No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Complaint is not confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
Additional Manufacturer Narrative
Investigation summary: a complaint investigation, due to different catalog labeling on the internal packaging on ceftazidime catalog 231633 batch 4156643, was performed.The investigation required to perform visual inspection, photos evaluation and batch record review.No discrepancies observed during the visual inspection.Retention samples were correct and correctly identified (cartridge and box).Returned goods were not received for the investigation.Batch record review did not show any evidence of customer claim.Photo received from customer was evaluated.No discrepancies observed.Product was correct and correctly identified (cartridge and box).Catalog number referenced in the cartridge label is used for product configuration of single and ten pack packaging.For ten pack configuration the box label will include a different catalog number.Since catalog 231633 is a ten pack, it will have a different catalog number in the box label, when compared with the catalog number referenced in the cartridge label.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Complaint is not confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
Event or Problem Description
It was reported prior to using the bd bbl¿ sensi-disc¿ ceftazidime 30 g, the user noted that the label of the cartridge containing the product (internal labeling) was different from the shelf package label (external label).No health impact or consequence reported.

• Brand Name: BD BBL¿ SENSI-DISC¿ CEFTAZIDIME 30 ¿G
• Common Device Name: SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21997189
• Report Number: 2647876-2025-00049
• Device Sequence Number: 18494683
• Product Code: JTN
• UDI-Device Identifier: 30382902316337
• UDI-Public: (01)30382902316337(11)240604(17)260604(10)4156643
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K852873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 06/04/2026
• Device Catalogue Number: 231633
• Device Lot Number: 4156643
• 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: 04/12/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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