MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ SENSI-DISC¿ CIPROFLOXACIN - 5 ¿G; SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Model Number	231658
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	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bbl¿ sensi-disc¿ ciprofloxacin - 5 ¿g the zone of inhabitation was larger than expected.This a report of 1 occurrence for two batch numbers (1127037, 1335457).No false results were reported out to the clinician or the patient.The following information was provided by the initial reporter: customer problem: customer is reporting 231658 has larger zone of inhibition than expected steps taken with customer/troubleshooting: customer is reporting their 231658 discs from lot 1127037 and 1335457 have a zone of inhibition of >38mm when the expected zone size should be 29mm to 38mm.No organism type was specified.The customer states they repeated with a fresh isolate and results were still over >38mm.They received a new lot number of discs, 1335458, and the qc passed as expected.
Additional Manufacturer Narrative
Batch number: 1127037.Batch exp.Date: 31-may-2024.Batch manufacture date: 07-may-2021.Batch number: 1335457.Batch exp.Date: 31-dec-2024.Batch manufacture date: 01-dec-2021.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary: a complaint investigation, due to zone sizes larger than expected on ciprofloxacin catalog 231658 batch no's.: 1335457; 1127037, was performed on retention samples.Returned goods were not received from customer.The investigation required to perform bauer kirby test, visual inspection, and batch record review.Retention samples from both lots 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.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 that while using bd bbl¿ sensi-disc¿ ciprofloxacin - 5 ¿g the zone of inhabitation was larger than expected.This a report of 1 occurrence for two batch numbers (1127037, 1335457).No false results were reported out to the clinician or the patient.The following information was provided by the initial reporter: customer problem: customer is reporting 231658 has larger zone of inhibition than expected steps taken with customer/troubleshooting: customer is reporting their 231658 discs from lot 1127037 and 1335457 have a zone of inhibition of >38mm when the expected zone size should be 29mm to 38mm.No organism type was specified.The customer states they repeated with a fresh isolate and results were still over >38mm.They received a new lot number of discs, 1335458, and the qc passed as expected.

• Brand Name: BD BBL¿ SENSI-DISC¿ CIPROFLOXACIN - 5 ¿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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14464492
• Report Number: 2647876-2022-00137
• Device Sequence Number: 4570429
• Product Code: JTN
• UDI-Device Identifier: 30382902316580
• UDI-Public: 30382902316580
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K874425
• 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): 07/01/2022

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 Model Number: 231658
• Device Catalogue Number: 231658
• Device Lot Number: SEE H.10
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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