MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ MARTIN-LEWIS AGAR; CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

Catalog Number 254029

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

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

It was reported while testing with bd bbl¿ martin-lewis agar, proteus species was not inhibited by the agar for twenty plates and overgrowth was observed.There was no health impact or consequences reported.

Manufacturer Narrative

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: it was reported that normally proteus spp are inhibited for growth on this medium due to the antibiotics that are included into the medium cfr package insert.With this lot the overgrowth of proteus spp is noticed.The complaint history was reviewed, and no similar complaints were reported for the affected catalog number.A trend was not identified.The batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Retain samples were analyzed in a performance test using proteus mirabilis atcc 43071, proteus mirabilis atcc 14153 and proteus mirabilis atcc 12453.No deviation was detected, and growth was still inhibited after 48 hours at 35-37°c in co2 atmosphere incubation.No return samples were provided by the customer for analysis.A picture was shared showing a plate with growth of bacteria.Based upon our investigation, we have excluded any systematic failure in our manufacturing process.All the release testing was satisfactory and additionally, the retest performed on the retain samples with proteus mirabilis atcc 43071, proteus mirabilis atcc 14153 and proteus mirabilis atcc 12453 was satisfactory.Since no trend was identified and no process deviation could be detected, further actions are not indicated at this point.Based on the results of the investigation and the evaluation of retain samples we cannot confirm this complaint.However, bd will continue monitoring incoming complaint with similar failure mode.

Event Description

It was reported while testing with bd bbl¿ martin-lewis agar, proteus species was not inhibited by the agar for twenty plates and overgrowth was observed.There was no health impact or consequences reported.

• Brand Name: BD BBL¿ MARTIN-LEWIS AGAR
• Type of Device: CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
• Manufacturer (Section D): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer (Section G): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18904319
• MDR Text Key: 337761380
• Report Number: 9680577-2024-00006
• Device Sequence Number: 1
• Product Code: JTY
• UDI-Device Identifier: 30382902540299
• UDI-Public: (01)30382902540299
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/26/2024
• Device Catalogue Number: 254029
• Device Lot Number: 3332386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2023
• 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