MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MUELLER HINTON II AGAR; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH

Model Number 221800

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

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

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 6 bd bbl¿ mueller hinton ii agar plates had differing bacterial growth results despite being from the same broth.New tests were performed with fresh broth and materials, but there was no growth for m.Luteus.There was no indication that results were reported, and there was no report of patient impact.The following information was provided by the initial reporter: "the customer reported growth issues with one of their bacteria (micrococcus luteus) when testing the mueller hinton plates received from lot 1347237.Different results were obtained when testing the same bacteria (from the same broth) on plates from their previous lot and the current lot.The bacteria only grew on the plate from the previous lot." "the broths used during the testing were 24-36 hours old.We redid everything with fresh material and attempted at least 10 different trials on this batch and none had any growth for m.Luteus." "yes, there was growth for the following bacteria: bacillus thuringiensis, enterobacter asburiae and staphylococcus epidermidis." "their m.Luteus strain is growing well on their old (expired) lot 1211750 but is not growing on the news lots received (1347273 and 2020098).".

Manufacturer Narrative

Correction: after further evaluation, this event was assessed as a quality control failure and will be cancelled.The diagnostic test is performed with the understanding and recommendation to perform concurrent controls to assure accuracy.Therefore, erroneous results would be suspected and lead to retesting.This will not likely lead to a serious adverse event.

Event Description

It was reported that 6 bd bbl¿ mueller hinton ii agar plates had differing bacterial growth results despite being from the same broth.New tests were performed with fresh broth and materials, but there was no growth for m.Luteus.There was no indication that results were reported, and there was no report of patient impact.The following information was provided by the initial reporter: "the customer reported growth issues with one of their bacteria (micrococcus luteus) when testing the mueller hinton plates received from lot 1347237.Different results were obtained when testing the same bacteria (from the same broth) on plates from their previous lot and the current lot.The bacteria only grew on the plate from the previous lot."."the broths used during the testing were 24-36 hours old.We redid everything with fresh material and attempted at least 10 different trials on this batch and none had any growth for m.Luteus."."yes, there was growth for the following bacteria: bacillus thuringiensis, enterobacter asburiae and staphylococcus epidermidis."."their m.Luteus strain is growing well on their old (expired) lot 1211750 but is not growing on the news lots received (1347273 and 2020098).".

Event Description

It was reported that 6 bd bbl¿ mueller hinton ii agar plates had differing bacterial growth results despite being from the same broth.New tests were performed with fresh broth and materials, but there was no growth for m.Luteus.There was no indication that results were reported, and there was no report of patient impact.The following information was provided by the initial reporter: "the customer reported growth issues with one of their bacteria (micrococcus luteus) when testing the mueller hinton plates received from lot 1347237.Different results were obtained when testing the same bacteria (from the same broth) on plates from their previous lot and the current lot.The bacteria only grew on the plate from the previous lot." "the broths used during the testing were 24-36 hours old.We redid everything with fresh material and attempted at least 10 different trials on this batch and none had any growth for m.Luteus." "yes, there was growth for the following bacteria: bacillus thuringiensis, enterobacter asburiae and staphylococcus epidermidis." "their m.Luteus strain is growing well on their old (expired) lot 1211750 but is not growing on the news lots received (1347273 and 2020098).".

Manufacturer Narrative

D.3 samples were received on 07apr2022.H.6 investigation summary: during manufacturing of material 221800, media is formulated and sent through a high temperature short time sterilizer to remove bioburden.The petri dishes are subjected to uv radiation to decrease bioburden.The petri dishes are filled in a positive pressure hepa filtered environment.The filled plates are cooled and immediately wrapped into sleeves to decrease the introduction of microbes.Sleeves are then packaged into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the distributor.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media of 2 to 8 degrees c in a dark place.The batch history record for batch 1347237 was satisfactory and no quality notifications were generated during manufacturing and inspection.All batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Mueller hinton agar is stability tested biennially for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis.All performance testing on this batch was satisfactory at the time of release.The complaint history was reviewed, and no other complaints have been taken on batch 1347237.Retention samples from batch 1347237 were not available for inspection.Twenty-four plates from batch 1347237 were returned as six unopened sleeves shipped in a box with paper padding (time stamps 1221 and 1240).Plates were tested with micrococcus luteus atcc 4698.Micrococcus is not routinely tested per the bd standard performance protocol for this product but was tested for investigations of this complaint.Atcc 4698 was streaked onto return plates from frozen (concentration approximately 10^6 cfu/ml) and had moderate growth and light-yellow colonies at 24 hours incubation at 33 to 37 degrees c.Likewise, a 0.5 mcfarland (approximately 10^8 cfu/ml) from fresh (24 hour) growth of atcc 4698 was streaked onto return plates.Moderate growth and yellow colonies were observed at 24 hours incubation at 33 to 37 degrees c.Two photos also were received for investigation.One photo shows the bottom of two plates.Each plate has eight discs stamped onto the surface but only one plate has growth.The other photo shows the bottom of six plates each with eight discs stamped onto the surface but only two plates have visible growth.No plate prints can be read for batch verification from the photos.It is followed that there was no growth where expected however, conclusions about performance cannot be made from photos.This growth of atcc 4698 was observed on the return samples tested from batch 1347237.This complaint cannot be confirmed.Bd will continue to trend complaints for performance.Risk management file review assessed the potential risk for the defect as severity s3 per baltrmppmgenpuraph, rev 02, id 1.6.

• Brand Name: BD BBL¿ MUELLER HINTON II AGAR
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14087803
• MDR Text Key: 289211159
• Report Number: 1119779-2022-00551
• Device Sequence Number: 1
• Product Code: JTZ
• UDI-Device Identifier: 10382902218002
• UDI-Public: 10382902218002
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMENDMENT
• 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,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/25/2022
• Device Model Number: 221800
• Device Catalogue Number: 221800
• Device Lot Number: 1347237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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