MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ CHROMAGAR® MRSA II 100MM (20 EACH); CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON

Catalog Number 257435

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

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ chromagar® mrsa ii 100mm (20 each), there was excessive growth seen on 10 plates across two lot numbers.The following information was provided by the initial reporter: "growth of mssa(methicillin susceptible staph.Aureus).During use, the customer contacted me because sometimes there are isolated mssa that grow on the mrsa chrome plate, look like mrsa but are confirmed to be sensitive by follow-up tests.Normally the growth of mssa should be inhibited but the customer noticed that mssa usually grow shortly before the expiry date ends but the plates are never used after the expiry date.As a confirmatory test, identification is always done with maldi-tof, a pbp2a test is carried out and then resistance in the (b)(6).No false results were sent to physicians.No patient was treated based on incorrect results and therefore there were no negative consequences".

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#: 3184609.D4.Medical device expiration date: 20-09-2023.H4.Device manufacture date: 03-07-2023.H.3.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 while using bd bbl¿ chromagar® mrsa ii 100mm (20 each), there was excessive growth seen on 10 plates across two lot numbers.The following information was provided by the initial reporter: "growth of mssa(methicillin susceptible staph.Aureus) during use the customer contacted me because sometimes there are isolated mssa that grow on the mrsa chrome plate, look like mrsa but are confirmed to be sensitive by follow-up tests.Normally the growth of mssa should be inhibited but the customer noticed that mssa usually grow shortly before the expiry date ends but the plates are never used after the expiry date.As a confirmatory test, identification is always done with maldi-tof, a pbp2a test is carried out and then resistance in the phoenix.No false results were sent to physicians.No patient was treated based on incorrect results and therefore there were no negative consequences.".

Manufacturer Narrative

H6: investigation summary: event description: the customer reported that mssa s.Aureus grow on the mrsa chrome plate, look like mrsa but are confirmed to be sensitive by follow-up tests.Normally the growth of mssa should be inhibited but the customer noticed that mssa usually grow shortly before the expiry date ends but the plates are never used after the expiry date.Complaint history review: the complaints trends were reviewed for a period covering 12 months.Similar complaints have been received for this catalog number; however, 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 mssa atcc 25923, s.Aureus mssa atcc 29213, s.Aureus mssa atcc 43387 and s.Aureus mssa wild limbach.Mssa strains were incubated aerobically for 42-48 h at 35-37 °c.No deviations were observed, and all results were within specification.No return samples were provided by the customer.Pictures illustrating purple colonies on the agar were shared.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.We are sorry for the inconvenience you have been experienced.Bd will continue to monitor incoming complaints with similar defects.

• Brand Name: BD BBL¿ CHROMAGAR® MRSA II 100MM (20 EACH)
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17936739
• MDR Text Key: 325834049
• Report Number: 9680577-2023-00044
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/11/2023
• Device Catalogue Number: 257435
• Device Lot Number: 3178696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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