MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MARTIN-LEWIS AGAR; CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

Model Number 221558

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

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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¿ martin-lewis agar atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that there are "poor results.".

Event Description

It was reported that while using bd bbl¿ martin-lewis agar atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that there are "poor results".

Manufacturer Narrative

H.6.Investigation: during manufacturing of material 221558, 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.No batch number, returns or photos were provided for investigation.Retention samples cannot be evaluated without a specific batch number.Trending was performed on the appropriate quality databases.A recall for three batches for martin lewis agar was issued on march 17, 2021 for misformulation: material 221558 batches 0317559 and 0345695 and material 221557 batch 0317558.No information provided from the customer acknowledges the use of the recall batches.The latest expiry of the recall batches was april 06, 2021 and this complaint was taken on july 22, 2021.This complaint cannot be confirmed.Bd will continue to trend complaints for performance.

• Brand Name: BD BBL¿ MARTIN-LEWIS AGAR
• Type of Device: CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12310853
• MDR Text Key: 266202312
• Report Number: 1119779-2021-01362
• Device Sequence Number: 1
• Product Code: JTY
• UDI-Device Identifier: 10382902215582
• UDI-Public: 10382902215582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K770287
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 221558
• Device Catalogue Number: 221558
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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