MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ OXIDASE REAGENT DROPPER; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Model Number 261181

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

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using bd bbl¿ oxidase reagent dropper there was no reaction.False results were confirmed using known qc organisms that should have a reaction.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that 261181 lot: b01c254m has no reaction.Customer reports the organisms she is an obvious clinical specimen that is pseudomonas aeruginosa.However the oxidase reaction is negative.No blue color change whatsoever.Customer waited a full minute and saw no color change at all.

Event Description

It was reported that while using bd bbl¿ oxidase reagent dropper there was no reaction.False results were confirmed using known qc organisms that should have a reaction.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that 261181 lot: b01c254m has no reaction.Customer reports the organisms she is an obvious clinical specimen that is pseudomonas aeruginosa.However the oxidase reaction is negative.No blue color change whatsoever.Customer waited a full minute and saw no color change at all.

Manufacturer Narrative

H.6.Investigation: this statement serves to summarize findings on the recent complaint 3677912 on product 261181 (dropper oxidase), lot number b01c254m, where it was some false negative reactions were observed.Event description: " customer reports 261181 lot: b01c254m has no reaction." complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of the device history record does not show any manufacturing issues.Sample analysis: the provided photo did show the noted defect.No returns were available.Retention samples were satisfactory.Evaluations results: based on the investigation, the photo showed a negative reaction on the paper from a plate that appeared to be p.Aeruginosa.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.As no deviations were observed in the investigation, no corrective or preventive actions are indicated at this time.However, bd will continue to monitor for trending.Investigation conclusion: based on the evaluation of the investigation, the complaint was confirmed on the photo.A definite root cause could not be determined.

• Brand Name: BD BBL¿ OXIDASE REAGENT DROPPER
• Type of Device: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12693637
• MDR Text Key: 282712470
• Report Number: 1119779-2021-01712
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 30382902611814
• UDI-Public: 30382902611814
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: 261181
• Device Catalogue Number: 261181
• Device Lot Number: B01C254M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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