MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL MACCONKEY II AGAR; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Model Number 221270

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/04/2021

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 that while using bd bbl¿ macconkey ii agar missing label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: " it was reported that customer reports sleeves are missing labels.¿ customer problem: customer reports sleeves are missing labels customer reports sleeves are missing labels.".

Manufacturer Narrative

Investigation: the batch history record for batch 0365665 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.Sample 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 typical levels.All physical attribute testing performed on this batch, including sleeve attributes, was satisfactory per our internal procedures.The complaint history was reviewed, and no other complaints have been taken on this batch for labeling.Retention samples from this batch were not available for inspection.One photo was received in lieu of returns for investigation.The photo shows one sleeve of medium rose-tan agar plates lifted out of the 100pack carton with no sleeve label visible on the featured sleeve.No other product labels are visible in the photo for batch verification.Without batch verification, the complaint cannot be confirmed by the photo.

Event Description

It was reported that while using bd bbl¿ macconkey ii agar missing label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: " it was reported that customer reports sleeves are missing labels.Customer problem: customer reports sleeves are missing labels customer reports sleeves are missing labels.".

• Brand Name: BD BBL MACCONKEY II AGAR
• Type of Device: CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11761621
• MDR Text Key: 279636423
• Report Number: 1119779-2021-00759
• Device Sequence Number: 1
• Product Code: JSI
• UDI-Device Identifier: 10382902212703
• UDI-Public: 10382902212703
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/02/2021
• Device Model Number: 221270
• Device Catalogue Number: 221270
• Device Lot Number: 0365665
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1