MAUDE Adverse Event Report: BECTON DICKINSON GMBH PLATE BBL CHROMAGAR MRSA II 90MM 20 EA; SEE H.10

Catalog Number 257434

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

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

Event Date 05/16/2023

Event Type  malfunction  

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 #: 3066580 d4.Medical device expiration date: 2023-05-24 h4.Device manufacture date: 2023-03-07 d.3 common device name :culture media, antimicrobial susceptibility test, excluding mueller hinton e.6 initial reporter e-mail: (b)(6) g5.There is no 510(k) for this device as it is manufactured outside the us and not sold in the us, but it is considered to be substantially similar to the legally u.S.Marketed device plate bbl chromagar mrsa ii 90mm 20 ea, catalog number 257434 with 510k #215228 h.6 investigation summary this memo is to summarize findings on the recent complaint (b)(4) against bbl¿ chromagar¿ mrsa ii, catalog number 257434, lot number 3058175 and 3066580 against agar shrinkage and dried out.Event description: it was reported that plates have arrived with little agar which means that after incubating the samples in the oven, the agar is quite dehydrated.Complaint history review: the complaint trends were reviewed.Similar complaints were reported for this catalog number; however, no trend was 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: the retain samples were reviewed and a deviation was not detected.Picture samples were provided showing media shrinkage and dried out.Evaluation results and investigation conclusion: based upon our investigation, we have excluded any systemic failure in our manufacturing process.No deviation could be detected neither during the review of the samples nor during the review of the production record.Bd manufactures various prepared plated media types, all of which contain around 95 % water.Agar shrinkage within the plates can be caused by various environmental factors linked to transportation and storage.A definite root cause was not identified.However, bd will continue to monitor incoming complaints for this type of defect.Based on the internal investigation and the picture samples provided, this complaint can be confirmed for agar shrinkage and dried out.We would suggest that you set aside, and not use, any prepared plated media that does not meet the appearance and performance specification as it is described on the bd certificate of analysis.This is consistent with industry recommendations for inspection of culture media prior to use (e.G.¿good practices for pharmaceutical microbiology laboratories¿, who technical report series, no.961, 2011, annex 2; chapter 1117 ¿microbiology best laboratory practices¿ the united states pharmacopeia; and the difco & bbl manual).

Event Description

It was reported that while using the plate bbl chromagar mrsa ii 90mm 20 ea that there was a performance issue.The following information was provided by the initial reporter: mrsa ii plates are not adequate for use.Plates have arrived with little agar which means that after incubating the samples in the oven, the agar is quite dehydrated.

• Brand Name: PLATE BBL CHROMAGAR MRSA II 90MM 20 EA
• Type of Device: SEE H.10
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17127240
• MDR Text Key: 317863451
• Report Number: 9680577-2023-00026
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/15/2023
• Device Catalogue Number: 257434
• Device Lot Number: 3058175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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