MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ SENSI-DISC¿ ERYTHROMYCIN 15 ¿G; SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Catalog Number	231290
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd bbl¿ sensi-disc¿ erythromycin 15 g a patient isolate tested sensitive, showing a clear no-growth zone around the disc for the drug erythromycin, but when compared to the instrumentation result it was resistant.No health impact or consequence reported.Report 2 of 2.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using the bd bbl¿ sensi-disc¿ erythromycin 15g a patient isolate tested sensitive, showing a clear no-growth zone around the disc for the drug erythromycin, but when compared to the instrumentation result it was resistant.No health impact or consequence reported.Report 2 of 2.
Additional Manufacturer Narrative
Investigation summary - a complaint investigation, due to no-growth zone observed around the disc for erythromycin catalog 231290 batch no.: 2243880, was performed on retention samples.Returned goods were not received from customer.The investigation required to perform bauer kirby test, visual inspection, batch record review and photo evaluation.Retention samples performed as expected.Refer to results below.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.Photos received from customer was evaluated.No hemolysis was observed around the clindamycin disc.Some hemolysis was observed around erythromycin disc.; however, the microorganism lawn can't be distinguished from the photo evaluation to identify any inhibition zone around any of the discs.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.Atcc zd limits results 49619 25-30 27-28 25923 22-30 25-26.

• Brand Name: BD BBL¿ SENSI-DISC¿ ERYTHROMYCIN 15 ¿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: 21395932
• Report Number: 2647876-2025-00011
• Device Sequence Number: 18079255
• Product Code: JTN
• UDI-Device Identifier: 30382902312902
• UDI-Public: (01)30382902312902(11)220831(17)260930(10)2243880
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: 09/30/2026
• Device Catalogue Number: 231290
• Device Lot Number: 2243880
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2022
• 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