MAUDE Adverse Event Report: BECTON DICKINSON GMBH 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 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

Common device name: culture media, antimicrobial susceptibility test, mueller hinton agar/broth.Initial reporter phone: (b)(6).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¿ mueller hinton ii agar biological contamination was found.The following information was provided by the initial reporter: biological contamination.

Manufacturer Narrative

H6 investigation summary: complaint history review: the complaints trends were reviewed and a similar complaint 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.Sample analysis: the retain samples were reviewed and no deviation could be detected.Return samples were not provided however a pictures sample were shared showing contaminated plates.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 we would suggest that you set aside, and not use, any prepared plated media that does not meet the appearance 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 bd bbl¿ mueller hinton ii agar biological contamination was found.The following information was provided by the initial reporter: biological contamination.

• Brand Name: BD BBL¿ MUELLER HINTON II AGAR
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16318677
• MDR Text Key: 309308996
• Report Number: 9680577-2023-00005
• Device Sequence Number: 1
• Product Code: JTZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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: 02/22/2023
• Device Catalogue Number: 254081
• Device Lot Number: 2333055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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