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 Missing Information (4053)

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

Event Date 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while testing with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) the label was missing from the product.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that the sleeve missing the product label.Call activity comment: customer problem: customer reports that sleeve missing the product label for cat 221261 lot 2040769.Indication that customer is industrial indu (if applicable): indu, is a letter signed by quality required (y/n)?: y, reviewed smax case history: y, help lightning attempt: n, help lightning success: n.Customer reports that sleeve missing the product label for cat 221261 lot 2040769.

Manufacturer Narrative

H6 investigation summary : this memo is to summarize findings regarding the complaint related to catalog number 221261, plate trypticase soy agar 5% sb 100 ea, batch number 2040769 and complaint number 4950369 for missing sleeve label.During manufacturing of material 221261, 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 batch 2040769 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical and sleeve attribute testing.Sample plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.They are tested for physical and sleeve attributes prior to release to ensure that they conform to typical levels.All physical and sleeve attribute testing performed on this batch was satisfactory per our internal procedures.The complaint history was reviewed, and no other complaints have been taken on batch 2040769.Retention samples from batch 2040769 were not available for inspection.One unopened sleeve (10 plates) from batch 2040769 were returned in a box with bubble wrap (time stamp 0816).The sleeve did not have a bd sleeve label, however there was a customer applied label and a remnant of a torn label on the sleeve.Three photos also were received for investigation.The photos each show a sleeve with medium-red agar plates and with no bd sleeve label visible.There is a customer applied label and the remnant of a torn label visible.This complaint can be confirmed.No complaint trend for missing sleeve labels has been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for missing sleeve labels.

Event Description

It was reported while testing with bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) the label was missing from the product.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that the sleeve missing the product label.Customer reports that sleeve missing the product label for cat 221261 lot 2040769.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14270085
• MDR Text Key: 290807990
• Report Number: 1119779-2022-00640
• Device Sequence Number: 1
• Product Code: JSG
• 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: 07/07/2022

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: Health Professional
• Device Expiration Date: 06/03/2022
• Device Catalogue Number: 221261
• Device Lot Number: 2040769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 05/03/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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