MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD DIFCO¿ OXGALL (DEHYDRATED FRESH BILE); SUPPLEMENT, CULTURE MEDIA

Catalog Number 212820

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

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

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd difco¿ oxgall (dehydrated fresh bile) that there was insufficient growth.The following information was provided by the initial reporter: the customer has stated that bacterial growth has been insufficient after switching to the current lot (1155481).

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2023-00039 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.

Event Description

It was reported that while using the bd difco¿ oxgall (dehydrated fresh bile) that there was insufficient growth.The following information was provided by the initial reporter: the customer has stated that bacterial growth has been insufficient after switching to the current lot (1155481).

• Brand Name: BD DIFCO¿ OXGALL (DEHYDRATED FRESH BILE)
• Type of Device: SUPPLEMENT, CULTURE MEDIA
• 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 ; 8015296192
• MDR Report Key: 16206594
• MDR Text Key: 308082040
• Report Number: 1119779-2023-00039
• Device Sequence Number: 1
• Product Code: JSK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/21/2023
• Device Catalogue Number: 212820
• Device Lot Number: 1155481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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