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

Model Number 231746

Device Problem False Positive Result (1227)

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

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd bbl¿ dryslide¿ oxidase 2 strain tests came back positive but should be negative.The following information was provided by the initial reporter: the media are columbia biomérieux and the strains are atcc reference strains all 3 strains are positive in less than 20 seconds while e.Coli and k.Pneumoniae should be negative.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 3008352382-2023-00084 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.

Event Description

It was reported that bd bbl¿ dryslide¿ oxidase 2 strain tests came back positive but should be negative.The following information was provided by the initial reporter: the media are columbia biomérieux and the strains are atcc reference strains all 3 strains are positive in less than 20 seconds while e.Coli and k.Pneumoniae should be negative.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17020624
• MDR Text Key: 316504131
• Report Number: 3008352382-2023-00084
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 30382902317464
• UDI-Public: 30382902317464
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K896398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: 231746
• Device Catalogue Number: 231746
• Device Lot Number: 2125485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1