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

Catalog Number 254053

Device Problem Contamination (1120)

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

Event Date 11/26/2021

Event Type  malfunction  

Manufacturer Narrative

There is no 510(k) for this device as it is manufactured outside the us and not sold in the us but is considered to be substantially similar to the legally u.S.Marketed device bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) catalog number 221239 with 510k number preamendment.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) contamination was discovered on the plates.The following information was provided by the initial reporter, translated from spanish to english: before use.Contaminated plates in bd packaging.

Manufacturer Narrative

H6: investigation summary: it was reported that several plates would be contaminated.The complaint trends were reviewed and for this product lot, no further complaints were reported.Therefore, a trend was not identified.The batch history review was performed.As part of the investigation, the ingredients of this medium were reviewed.During this review, no deviation was detected.Picture sample was provided showing contaminated plates.Retain samples were reviewed for this lot.During this review no contamination was detected.At this stage of our investigation, we have excluded any systemic failure in our manufacturing process.Please note that this product does not have an sal (sterility assurance level) claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.Based on the evaluation of the report and the pictures the complaint is confirmed.

Event Description

It was reported that prior to use with bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) contamination was discovered on the plates.The following information was provided by the initial reporter, translated from spanish to english: before use.Contaminated plates in bd packaging.

• 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 GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer (Section G): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13055358
• MDR Text Key: 286889302
• Report Number: 9680577-2021-00100
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial
• Report Date: 03/08/2022

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: 01/19/2022
• Device Catalogue Number: 254053
• Device Lot Number: 1285549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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