MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ DRYSLIDE¿ OXIDASE; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Catalog Number	231746
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	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6.Investigation summary: a complaint investigation due to color change was not observable by oxidase positive organism when using dryslide oxidase catalog 231746, batch no.: 2277390 was performed on retention samples.Returned goods were not received from customer.The investigation required to test product for performance, visual inspection, and batch record review.Retention samples performed as expected.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.H3 other text: see h.10.
Event or Problem Description
It was reported that while using bd bbl¿ dryslide¿ oxidase, color change was not observable by oxidase positive organism pseudomonas.No patient impact reported."test performs not as expected: color change was not observable by oxidase positive organism (pseudomonas) , it remained colorless during use were patient samples involved?: yes".
Additional Manufacturer Narrative
H3.Investigation summary: a complaint investigation due to color change was not observable by oxidase positive organism when using dryslide oxidase catalog 231746 batch no.: 2277390.Returned goods were not received from customer.The investigation required to test product for performance, visual inspection, and batch record review was performed on retention samples.Retention samples performed as expected.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.H3 other text : see h10.
Event or Problem Description
It was reported that while using bd bbl¿ dryslide¿ oxidase, color change was not observable by oxidase positive organism pseudomonas.No patient impact reported."test performs not as expected: color change was not observable by oxidase positive organism (pseudomonas) , it remained colorless.During use.Were patient samples involved? yes.".
Additional Manufacturer Narrative
The following update has been made: awareness date: 19-sep-2023.
Event or Problem Description
It was reported that while using bd bbl¿ dryslide¿ oxidase, color change was not observable by oxidase positive organism pseudomonas.No patient impact reported."test performs not as expected: color change was not observable by oxidase positive organism (pseudomonas) , it remained colorless.During use.Were patient samples involved? yes.".

• Brand Name: BD BBL¿ DRYSLIDE¿ OXIDASE
• Common Device Name: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 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: 17953732
• Report Number: 2647876-2023-00251
• Device Sequence Number: 20474370
• Product Code: JTO
• UDI-Device Identifier: 30382902317464
• UDI-Public: (01)30382902317464
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K896398
• 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): 10/23/2023

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: 10/31/2023
• Device Catalogue Number: 231746
• Device Lot Number: 2277390
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 09/19/2023; 10/23/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 10/23/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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