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 03/25/2022

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 while using bd bbl¿ mueller hinton ii agar the customer observed that the media had atypical growth.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "[customer] reported further growth issues with their m.Luteus strain when testing the new lot of mueller hinton ii agar plates received (lot 2020098 / 0800/ 2022/05/02).According to the attached photo, their m.Luteus strain is growing well on their old (expired) lot 1211750 but it's not growing on the two last lots received (1347273 and 2020098).The same broth tube was used to inoculate the 3 lots and the plates were all incubated at 37 degrees c for 48h.".

Event Description

It was reported that while using bd bbl¿ mueller hinton ii agar the customer observed that the media had atypical growth.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "[customer] reported further growth issues with their m.Luteus strain when testing the new lot of mueller hinton ii agar plates received (lot 2020098 / 0800/ 2022/05/02).According to the attached photo, their m.Luteus strain is growing well on their old (expired) lot 1211750 but it's not growing on the two last lots received (1347273 and 2020098).The same broth tube was used to inoculate the 3 lots and the plates were all incubated at 37 degrees c for 48h.".

Manufacturer Narrative

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 2020098 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 2020098.Retention samples from batch 2020098 were not available for inspection.One photo was received for investigation.The 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.No samples were received for investigation.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: 14173966
• MDR Text Key: 290051759
• Report Number: 1119779-2022-00584
• 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: NA
• 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: 10/26/2022

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: 05/02/2022
• Device Model Number: 221800
• Device Catalogue Number: 221800
• Device Lot Number: 2020098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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