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

Catalog Number 231746

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

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 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".

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 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.".

Manufacturer Narrative

The following update has been made: awareness date: 19-sep-2023.

Event 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
• Type of Device: 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
• MDR Text Key: 325952889
• Report Number: 2647876-2023-00251
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 30382902317464
• UDI-Public: (01)30382902317464
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K896398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1