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

Catalog Number 221261

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

It was reported that prior to using bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii), two sleeves were received with growth on them.No patient impact reported.The following information was provided by the initial reporter: "customer reports receiving plates with growth on them.".

Manufacturer Narrative

D.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that prior to using bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii), two sleeves were received with growth on them.No patient impact reported.The following information was provided by the initial reporter: "customer reports receiving plates with growth on them.".

Manufacturer Narrative

H.6.Investigation summary: two photos were received for investigation.One photo shows the side of a sleeve with growth visible in the top plate.The other photo shows the side of a sleeve with one darker color from contamination highlighted.No return samples were received for investigation.No batch number was provided for investigation.Retention samples cannot be evaluated without a specific batch number.The appropriate quality databases were reviewed, and bd identified a contamination trend for this product that would include batches still within expiry at the time this complaint was taken.The 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 part of the implementation with an ongoing training review for cleaning processes.Improvement in observation of contamination is expected.This complaint can be confirmed based on the trend.Bd will continue to trend complaints for contamination.

• Brand Name: BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17653291
• MDR Text Key: 322318298
• Report Number: 1119779-2023-00958
• Device Sequence Number: 1
• Product Code: JSG
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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 Catalogue Number: 221261
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/25/2024
• 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