MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL MUELLER HINTON II AGAR, 100 PLATES; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH

Catalog Number 251275

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that the bd bbl mueller hinton ii agar, 100 plates had printing defects found before use.There was no health impact or consequences reported.

Manufacturer Narrative

The manufacturing location for this product is fukushima, japan.This site is an oem manufacturing site.Therefore, bd in sparks, md has been listed in sections d.3.And g.1.And the sparks fda registration number has been used for the manufacture report number.B3: date of event is unknown.The date received by manufacturer has been used for this field.H.3.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 the bd bbl mueller hinton ii agar, (b)(4) plates had printing defects found before use.There was no health impact or consequences reported.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 22-jan-2024.H.6.Investigation summary: bd received customer returns and photos for investigation.The printing issue(no printing and missed print) was confirmed on the return samples and photos.Retention samples were inspected with no issues identified.Device history record review revealed a dish jammed during production.This complaint has been confirmed for printing errors.Bd determined that the root cause of the indicated failure mode was attributed to an operator error.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD BBL MUELLER HINTON II AGAR, 100 PLATES
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18659485
• MDR Text Key: 334786459
• Report Number: 1119779-2024-00088
• Device Sequence Number: 1
• Product Code: JTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/04/2024
• Device Catalogue Number: 251275
• Device Lot Number: 3311118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2023
• 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