MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ CHROMAGAR® MRSA II 100MM (20 EACH); SEE H.10

Catalog Number 252353

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

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

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

Common device name: culture media, antimicrobial susceptibility test, excluding mueller hinton.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¿ chromagar® mrsa ii 100mm (20 each) reddish purple colonies were observed.The following information was provided by the initial reporter: according to the customer's report, reddish purple colonies were observed, and they were identified as mssa by pot method, while reddish purple bacteria should have been mrsa.

Event Description

It was reported that bd bbl¿ chromagar® mrsa ii 100mm (20 each) reddish purple colonies were observed.The following information was provided by the initial reporter: according to the customer's report, reddish purple colonies were observed, and they were identified as mssa by pot method, while reddish purple bacteria should have been mrsa.

Manufacturer Narrative

D9.Device available for evaluation? yes.Returned to manufacturer on: 09-jun-2023.H6.Investigation summary: bd received customer return samples and 2 photos for investigation.The photos were reviewed, however photos cannot confirm performance complaints.Material and lot # was verified from the photos.Additionally, the customer samples along with retention samples from bd inventory, were subjected to qc testing.All testing was within specification; all testing passed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for atypical growth.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD BBL¿ CHROMAGAR® MRSA II 100MM (20 EACH)
• Type of Device: SEE H.10
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16892472
• MDR Text Key: 314813490
• Report Number: 1119779-2023-00536
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092767
• 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
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/24/2023
• Device Catalogue Number: 252353
• Device Lot Number: 3031958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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