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	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 1127037, medical device expiration date: 05/31/24, device manufacture date: 05/07/21.Device evaluated by mfr: 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 that while using the customer bd bbl¿ sensi-disc¿ ciprofloxacin - 5 g.This event occurred 1 time(s).At this time it is unclear whether or not patient samples were involved.There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "customer is reporting a zone of inhibition for their 231658 disc that is larger 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.".
Additional Manufacturer Narrative
Investigation summary: a complaint investigation due to a zone of inhibition is larger than expected for ciprofloxacin catalog 231658 batch no's.: 1335457, 1127037 were 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 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.
Event or Problem Description
It was reported that while using + the customer bd bbl¿ sensi-disc¿ ciprofloxacin - 5 ¿g.This event occurred 1 time(s).At this time it is unclear whether or not patient samples were involved.There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "customer is reporting a zone of inhibition for their 231658 disc that is larger 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.".

• 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: 14289083
• Report Number: 2647876-2022-00120
• Device Sequence Number: 1532540
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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 Expiration Date: 12/31/2024
• Device Model Number: 231658
• Device Catalogue Number: 231658
• Device Lot Number: 1335457
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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