MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Catalog Number 215081

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

D4.Medical device lot#: unknown d4.Medical device expiration date: unknown h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H4.Device manufacture date: unknown.

Event Description

It was reported that while using bd bbl¿ chromagar¿ orientation agar, the package insert has incorrect information.No patient impact reported.

• Brand Name: BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18243396
• MDR Text Key: 329454335
• Report Number: 1119779-2023-01281
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 00382902150817
• UDI-Public: (01)00382902150817
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 215081
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• 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