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 251239

Device Problem Contamination (1120)

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

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

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 prior to use with bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) "black" foreign matter was discovered in the media.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, black spots were found in the media and the affected media was thus not used.

Manufacturer Narrative

H.6.Investigation summary: 251239 #3143197.We could confirm this issue as a report from returned sample and photo.This issue was contamination.No issue in retention sample.No issue in dhr.No trend.Root cause was undetermined.We will continue to monitor this lot.The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes.D9: returned to manufacturer on: 12-oct-2023 h3 other text : see h.10.

Event Description

It was reported that prior to use with bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) "black" foreign matter was discovered in the media.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, black spots were found in the media and the affected media was thus not used.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17507397
• MDR Text Key: 320881014
• Report Number: 1119779-2023-00871
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 10/17/2023

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: 09/21/2023
• Device Catalogue Number: 251239
• Device Lot Number: 3143197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2023
• 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