MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE HELICOBACTER AGAR 90MM 20

Catalog Number 254430

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

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

Event Date 02/19/2023

Event Type  malfunction  

Event Description

It was reported that while using the plate helicobacter agar 90mm 20 that there was no growth.The following information was provided by the initial reporter: "no bacterial growth on the helicobacter agar plates, not only specimens, even when using qc strains!".

Manufacturer Narrative

Date of event is unknown.The date received by manufacturer has been used for this field.Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: PLATE HELICOBACTER AGAR 90MM 20
• Type of Device: NA
• 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 ; 8448235433
• MDR Report Key: 16496479
• MDR Text Key: 310967950
• Report Number: 1119779-2023-00237
• Device Sequence Number: 1
• Product Code: LYR
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/21/2023
• Device Catalogue Number: 254430
• Device Lot Number: 3009313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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