MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MUELLER HINTON II AGAR; SEE H.10

Catalog Number 254081

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

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

Event Date 03/14/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd bbl¿ mueller hinton ii agar that there was contamination.The following information was provided by the initial reporter: arrived with contamination.

Manufacturer Narrative

There was another lot number reported to be involved.The information for that lot number is as follows: medical device lot #: 3024165, medical device expiration date: 2023-04-16, device manufacture date: 2023-01-24, common device name: culture media, antimicrobial susceptibility test, mueller hinton agar/broth.Initial reporter phone and address (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: complaint history review: the complaints trends were reviewed, and similar complaints was registered.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 for both lot numbers.Sample analysis: the retain samples were reviewed and no deviation could be detected.Return samples were not provided; however, pictures sample were shared showing contaminated plates for both lot numbers.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.This product does not have an sal (sterility assurance level) claim.It is filled aseptically; therefore, an occurrence of a contamination event cannot be entirely ruled out.Please note that the valid standard for these products is din en 12322 "in vitro diagnostic medical devices - culture media for microbiology".According to this standard the contamination rate for each product lot must not exceed 4.9%.Based upon our continuous monitoring, we derive a contamination rate that falls below this specified value.According to our high-quality standard, we only release product batches to the market with an aql (acceptable quality level) = 0,65.Although this contamination level is very low, we cannot completely exclude that a customer may receive contaminated plates.Investigation conclusion: based on the evaluation and the provided picture, the complaint was confirmed for contamination.A definite root cause could not be determined.Bd regrets the inconveniences you have experienced due to this issue and will continue monitoring incoming similar complaints.

Event Description

It was reported that while using the bd bbl¿ mueller hinton ii agar that there was contamination.The following information was provided by the initial reporter: arrived with contamination.Pictures attached.

• Brand Name: BD BBL¿ MUELLER HINTON II AGAR
• 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: 16588921
• MDR Text Key: 312226985
• Report Number: 1119779-2023-00310
• Device Sequence Number: 1
• Product Code: JTZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/26/2023
• Device Catalogue Number: 254081
• Device Lot Number: 3003058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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