MAUDE Adverse Event Report: BECTON DICKINSON GMBH PLATE BBL CHROMAGAR MRSA II 90MM 20 EA; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON

Catalog Number 257434

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

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

H.6.Investigation summary: complaint history review: the complaints trends were reviewed for a period covering 12 months.No similar complaints have been received for this lot number.A trend was not identified.Batch history record (bhr) review: the batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Sample analysis: a functionality test was performed on retain samples.Tested strains were s.Aureus mrsa atcc33592, s.Aureus mrsa atcc43300, s.Epidermidis mssa atcc 12228, s.Aureus mssa atcc25923, s.Aureus mssa atcc29213, s.Aureus mssa atcc43367 and s.Aureus mssa wild limbach.S.Aureus mrsa strains were incubated aerobically for 20-22 h at 35-37 °c.Mssa strains were incubated 42-48 h at 35-37 °c.No deviations were observed, and all results were within specification.No return samples were provided.Evaluation results and investigation conclusion: at this stage of our investigation, we have excluded any systemic failure in our production process.No deviation could be found during the qc release performance test and the performance test on the retain samples.Based on the evaluation and on the test results, the complaint was not confirmed.H3 other text: see h.10.

Event Description

It was reported that during use with an unspecified amount of plate bbl chromagar mrsa ii 90mm there are no proper colonies, just a pink haze, however we are concerned this may be mistaken for a positive mrsa.The following information was provided by the initial reporter: "we have been having a few issues lately with non-mrsa s.Aureus growing pink on the mrsa chrome.There are no proper colonies, just a pink haze, however we are concerned this may be mistaken for a positive mrsa.".

• Brand Name: PLATE BBL CHROMAGAR MRSA II 90MM 20 EA
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON
• Manufacturer (Section D): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer (Section G): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17607379
• MDR Text Key: 321819553
• Report Number: 9680577-2023-00037
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/22/2023
• Device Catalogue Number: 257434
• Device Lot Number: 3156130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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