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

Model Number 221800

Device Problem Low pH (4005)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd bbl¿ mueller hinton ii agar that there was a performance issue.The following information was provided by the initial reporter: steps taken with customer/troubleshooting: customer states product ph is measuring too low (multiple calibrations and testing attempts performed).Lot # 3094846 ph measuring 7.13/7.12 and lot # 3101064 ph measuring 7.11.

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 #: 3094846.D4.Medical device expiration date: 2023-07-19.H4.Device manufacture date: 2023-04-04.D.3 common device name: culture media, antimicrobial susceptibility test, mueller hinton agar/broth.E.7 initial reporter addr 1: (b)(6).H.3.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 the bd bbl¿ mueller hinton ii agar that there was a performance issue.The following information was provided by the initial reporter: steps taken with customer/troubleshooting: customer states product ph is measuring too low (multiple calibrations and testing attempts performed).Lot # 3094846 ph measuring 7.13/7.12 and lot # 3101064 ph measuring 7.11.

Manufacturer Narrative

The following fields were updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 22-may-2023.The following field has been corrected: h.6 - imdrf annex f code - f26.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 batches 3094846 and 3101064 were satisfactory and no quality notifications were generated during manufacturing and inspection of either batch.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 ii 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 these batches were satisfactory at the time of release.The complaint history was reviewed, and no other complaints have been taken on either batch 3094846 or 3101064 for ph variance.Retention samples from batches 3094846 and 3101064 were not available for inspection.Five plates from batch 3094846 (time stamp 0835) were returned as one unopened sleeve and five plates from batch 3401064 (time stamp 1119) were retuned as one unopened sleeve shipped in an insulated box with ice packs and returns for one other batch.Return samples were ph tested and the average ph of the five plates from batch 3094846 was 7.3.Likewise, the average ph of five plates from batch 3101064 was 7.3.The ph specification for this product is 7.2 to 7.4 when taken at 23 to 27 degrees c.No photos were received for investigation.The ph of the product may vary depending on the age of the product and the type of ph meter and probe used, however return samples tested within ph specifications.This complaint cannot be confirmed.Bd will continue to trend complaints for ph variance.

• 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: 17112076
• MDR Text Key: 317040050
• Report Number: 1119779-2023-00640
• Device Sequence Number: 1
• Product Code: JTZ
• UDI-Device Identifier: 10382902218002
• UDI-Public: 10382902218002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/26/2023
• Device Model Number: 221800
• Device Catalogue Number: 221800
• Device Lot Number: 3101064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2023
• 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