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

Model Number 221353

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.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 while using the bd bbl¿ columbia cna agar with 5% sheep blood that there was a missing label.The following information was provided by the initial reporter: quantity received and quantity affected: 1 case.Customer reporting opened pack and missing label of product 221353.

Manufacturer Narrative

H.6.Investigation summary: during manufacturing of material 221353, 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.Two photos were received for investigation.One photo shows a sleeve with no sleeve label and two sleeves with labels in the background.The information on the sleeve labels in the background cannot be read.The other photo shows a 100pack carton opened from the side with a stack of 10 plates in the box with the sleeve material next to it.No product labels are in the photo.No batch number or return samples were provided for investigation of this complaint.Without a batch number, further investigation into the defects cannot be made.Retention samples cannot be evaluated without a specific batch number.Trending was performed on the appropriate quality databases and no trends for missing sleeve labels or packaging defects were found in the last 12 months.The complaint history was reviewed for material 221353 and there are no trends for missing sleeve label or packaging defects in any batch over the last 12 months.Bd will continue to trend complaints for missing sleeves labels and packaging defects.This complaint cannot 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.The packaging of the sleeves of this product into cartons also is an automated process.While what is shown in the photo of a stack of plates and the sleeve material being separated in the carton could occur during the packaging process, it cannot be investigated without a specific batch number affected.

Event Description

It was reported that while using the bd bbl¿ columbia cna agar with 5% sheep blood that there was a missing label.The following information was provided by the initial reporter: quantity received and quantity affected: 1 case customer reporting opened pack and missing label of product 221353.

• Brand Name: BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD
• Type of Device: CULTURE MEDIA, 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17130762
• MDR Text Key: 317562527
• Report Number: 1119779-2023-00657
• Device Sequence Number: 1
• Product Code: JSJ
• UDI-Device Identifier: 10382902213533
• UDI-Public: 10382902213533
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 221353
• Device Catalogue Number: 221353
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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