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

Catalog Number 254007

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: event description: the customer reported several plates being not selective for gram negative bacteria.Complaint history review: the complaint history has been reviewed for a period of 12 months and a similar issue was reported; however no trend was identified.Batch history record (bhr) review: the batch history has been reviewed and no deviation was recorded.All the release testing was satisfactory.Sample analysis: a performance test has been conducted on the retaining samples for the strains that should be inhibited (atcc 27853 ; ps.Aeruginosa and atcc 12453; prot.Mirabilis) with excellent results.The strains were inhibited.Return samples were not provided however picture illustrating a plate with bacterial growth was provided.Evaluation results: based upon our investigation, we have excluded any systematic failure in our manufacturing process.All the release testing was satisfactory and also the retest performed on the retain samples with atcc 27853 (ps.Aeruginosa) and atcc 12453 (prot.Mirabilis) did not reveal any deviation to the requirement.Since no trend was identified and no process deviation could be detected, no action will be conducted this time.Investigation conclusion: based on the above mentioned investigations and testing, we cannot confirm this complaint.However bd will continue monitoring incoming complaint with similar failure mode.

Event Description

It was reported while using bd bbl¿ columbia cna agar with 5% sheep blood, excessive growth was observed.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that a non-conformity has been detected with sabouraud dextrose agar + gentamycin product code.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15222014
• MDR Text Key: 304986803
• Report Number: 1119779-2022-01099
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 07/27/2022

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: Health Professional
• Device Expiration Date: 08/24/2022
• Device Catalogue Number: 254007
• Device Lot Number: 2150288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2022
• 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