MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ SENSI-DISC¿ COLISTIN - 10 ¿G; SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Catalog Number	231278
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 prior to using bd bbl¿ sensi-disc¿ colistin - 10 g, five boxes arrived with incorrect label information.No patient impact reported.The following information was provided by the initial reporter: "customer ordered bd 231278 disc colistin cl-10 however they received bd 230749 inside the box.Same lot number and expiry date however they have different bd item/sku number based on the box and its actual product inside.".
Event or Problem Description
It was reported that prior to using bd bbl¿ sensi-disc¿ colistin - 10 ¿g, five boxes arrived with incorrect label information.No patient impact reported.The following information was provided by the initial reporter: "customer ordered bd 231278 disc colistin cl-10 however they received bd 230749 inside the box.Same lot number and expiry date however they have different bd item/sku number based on the box and its actual product inside.".
Additional Manufacturer Narrative
H.6 investigation summary: a complaint investigation due to incorrect label for colistin catalog 231278 batch no.: 8426744 was performed on retention samples.The investigation required to perform visual inspection, batch record review and customer photo evaluation.No discrepancies observed during retention samples visual inspection.Photo received from customer was evaluated.It was observed that product was identified correctly.Single cartridge is identified with catalog 230749 while product package (ten pack) is identified with catalog 231278.Catalogs 230749 and 231278 are correct for colistin product.Batch record review did not show any evidence of customer claim.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.H3 other text : see h.10.
Additional Manufacturer Narrative
The following fields have been updated: b5.It was reported prior to using bd bbl¿ sensi-disc¿ colistin - 10 g, a box contained a different product than was indicated by the label.There was no report of patient impact.This supplemental mdr is being submitted as part of a retrospective review of records dating april 2023¿2025, under capa 11910483.
Event or Problem Description
It was reported prior to using bd bbl¿ sensi-disc¿ colistin - 10 g, a box contained a different product than was indicated by the label.There was no report of patient impact.

• Brand Name: BD BBL¿ SENSI-DISC¿ COLISTIN - 10 ¿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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17424585
• Report Number: 2647876-2023-00090
• Device Sequence Number: 12693059
• Product Code: JTN
• UDI-Device Identifier: 30382902312780
• UDI-Public: 30382902312780
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: PREAMENDMENT
• 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,Followup
• Report Date (Section B): 08/14/2025

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: 08/31/2026
• Device Catalogue Number: 231278
• Device Lot Number: 2210171
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 09/08/2023; 09/10/2025
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 09/20/2023; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• 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