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

Model Number 221734

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: 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 that bd bbl¿ cdc anaerobe 5% sheep blood agar arrived with missing labels.The following information was provided by the initial reporter: 2 packs of product were missing labels.Hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.

Manufacturer Narrative

H.6 investigation summary: during manufacturing of material 221734, 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 2257823 was satisfactory and no quality notifications were generated during manufacturing and inspection.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 the only other complaint taken on this batch was also from lifenet health for missing sleeve labels.No retention samples from batch 2257823 were available for inspection.One hundred plates from batch 2257823 were returned as 10 unopened sleeves shipped in a retaped 100pack carton (carton number 0107, time stamps 1358-1400).One of the returned sleeves did not have a sleeve label and another one of the returned sleeves had the torn back of a sleeve label.Two photos also were received for investigation.One photo shows two sleeves, one with a sleeve label from batch 2257823 and the other with torn label backing.The other photo also shows two sleeves, one sleeve does not have a sleeve label and the other has torn label backing.This complaint can be confirmed.This product is packaged into sleeves and labeled via an automated process.If a failure in the sleeve labeling process occurs, each plate of this product is labeled so the media type, batch number and expiration date are readily available.This complaint can be confirmed.No complaint trends for labeling defects have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for labeling defects.

Event Description

It was reported that bd bbl¿ cdc anaerobe 5% sheep blood agar arrived with missing labels.The following information was provided by the initial reporter: 2 packs of product were missing labels.Hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.

• Brand Name: BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR
• 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: 15991959
• MDR Text Key: 308089746
• Report Number: 1119779-2022-01494
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 10382902217340
• UDI-Public: 10382902217340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803025
• 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: 04/20/2023

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: 12/29/2022
• Device Model Number: 221734
• Device Catalogue Number: 221734
• Device Lot Number: 2257823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1