MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number 221291

Device Problem Contamination (1120)

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

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that prior to use, bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) // macconkey ii agar plates were contaminated.The following information was provided by the initial reporter: customer is reporting contamination.

Event Description

It was reported that prior to use, bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) // macconkey ii agar plates were contaminated.The following information was provided by the initial reporter: customer is reporting contamination.

Manufacturer Narrative

H.6 investigation summary: during manufacturing of material 221291, 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.No batch number, returns or photos were provided for investigation.Retention samples cannot be evaluated without a specific batch number.Trending was performed on the appropriate quality databases and no trends for broken plates were found in the last 12 months.The complaint history was reviewed for material 221291 and there are no trends for broken plates in any batch over the last 12 months.A trend was identified for contamination and investigation found opportunities for bioburden reduction in the manufacturing process.A capa (corrective and preventative actions) has been initiated and involves implementing additional cleaning events and evaluation of manufacturing procedures focused on in-process bioburden reduction.Additional trainings are planned with an ongoing training review for cleaning processes.This complaint can be confirmed for contamination based on trend identified.However, this complaint cannot be confirmed for broken plates.Bd will continue to trend complaints for contamination and broken plates.Capa #3076308 h3 other text : see h.10.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• 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: 13028279
• MDR Text Key: 288370587
• Report Number: 1119779-2021-01989
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 10382902212918
• UDI-Public: 10382902212918
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

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 Model Number: 221291
• Device Catalogue Number: 221291
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 10/03/2022
• Supplement Dates FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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