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

Catalog Number 221734

Device Problem Missing Information (4053)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

It was reported that prior to using bd bbl¿ cdc anaerobe 5% sheep blood agar, there were 4 boxes of plates with missing labels.No patient impact reported.The following information was provided by the initial reporter: "4 boxes of plates 221734, lot#: 3200741 with missing labels and "glue" smear all over.".

Manufacturer Narrative

E.1.Initial reporter phone #: (b)(6).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

H.6.Investigation summary: the batch history record for batch 3200741 was satisfactory per internal procedures.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 internal procedures.The complaint history was reviewed, and no other complaints have been taken on batch 3200741 for labeling defects.No retention samples from batch 3200741 were available for inspection.Three unopened sleeves (30 plates) were returned for investigation of this complaint.Each sleeve had a sleeve label, but the information is not readable due to light or fading print (time stamps 0438 and 0717).Three photos also were received for investigation.One photo features a sleeve label from batch 3200741 with print that is slightly faded but still readable.Another photo shows five sleeves where one sleeve does not have a label, two sleeves appear to have print that is faded, and two sleeves appear to have information missing from the labels.The last photo shows a sleeve label with faded print that is not legible.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 for missing sleeve label and illegible sleeve labels.No complaint trend for labeling defects has been identified; no actions are indicated at this time per bd procedures.Bd will continue to trend complaints for labeling defects.

Event Description

It was reported that prior to using bd bbl¿ cdc anaerobe 5% sheep blood agar, there were 4 boxes of plates with missing labels.No patient impact reported.The following information was provided by the initial reporter: "4 boxes of plates 221734, lot#: 3200741 with missing labels and "glue" smear all over.".

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17856966
• MDR Text Key: 324993475
• Report Number: 1119779-2023-01041
• 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: 04/23/2024

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: 10/25/2023
• Device Catalogue Number: 221734
• Device Lot Number: 3200741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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