MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 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 09/15/2023

Event Type  malfunction  

Event Description

It was reported that bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) plates were received and upon visual inspection the associate noticed some of the plates were missing label information.This was discovered prior to use, and no impact to patient testing was reported.Verbiage from r&d associate: tsa ii (221261).Lot 3205296 had pitting of agar, bubbles, media under-fill and missing/clumped ink jet plate information.These four defects were observed on a single plate.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been updated with additional information: device return to manuf.Yes.Returned to manufacturer on: 09/28/2023.H.6.Investigation summary: 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 3205296 was satisfactory per internal procedures.The release testing that is performed on this product does include physical attribute testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.They are tested for physical attributes prior to release to ensure that they conform to product specifications.All physical attribute testing performed on this batch was satisfactory per bd internal procedures.The complaint history was reviewed, and no other complaints have been taken on batch 3205296.Retention samples from batch 3205296 were not available for inspection.Five plates from batch 3205296 were returned for investigation as loose plates taped together in a bag (time stamps 0331 and 0332).Plates were inspected and 5/5 plates had less than expected media, 5/5 plates had pits and bubbles on the agar surface and 1/5 plates had agar bed fallout.No plate print defects, missing or illegible print, was seen in the return samples.Two photos also were received for investigation.One photo shows a plate with a compacted plate print and the media does not cover the plate bottom completely.The other photo shows the agar surface of a plate with pits and a bubble on the agar surface and the media that does not completely cover fill the plate bottom.This complaint can be confirmed for agar defects and plate print defects.No complaint trend for fallout, surface defects, fill defects or labeling has been identified with this product; no actions are indicated at this time.Bd will continue to trend complaints for defects.

Event Description

It was reported that bd bbl¿ trypticase soy agar with 5% sheep blood (tsa ii) plates were received and upon visual inspection the associate noticed some of the plates were missing label information.This was discovered prior to use, and no impact to patient testing was reported.Verbiage from r&d associate: tsa ii (221261) lot 3205296 had pitting of agar, bubbles, media under-fill and missing/clumped ink jet plate information.These four defects were observed on a single plate.

• 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.; 250 schilling circle; cockeysville MD 21030
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 250 schilling circle; cockeysville MD 21030
• Manufacturer Contact: jennifer suh ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 17951377
• MDR Text Key: 326418047
• Report Number: 1111096-2023-00001
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902212615
• UDI-Public: (01)30382902212615
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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 Expiration Date: 11/14/2023
• Device Catalogue Number: 221261
• Device Lot Number: 3205296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2023
• 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