MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD; SEE H.10

Catalog Number 251801

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

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Common device name: culture media, antimicrobial susceptibility test, mueller hinton agar/broth.

Event Description

It was reported that bbl - mueller hinton agar with 5% sheep blood mold was found in the media before use.The following information was provided by the initial reporter: mold was found in the media before usage.

Manufacturer Narrative

H.6 investigation summary: we couldn't confirm this issue as a report because no photo and returned sample.Complaint history was reviewed, and no other complaint has been taken on this lot at this time.Device history record did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.It includes bioburden testing.A visual inspection was performed on 20 retention samples of this lot.As a result, no defect was observed.The root cause for this could not be determined.We will continue to monitor this lot.H3 other text : see h.10.

Event Description

It was reported that bbl - mueller hinton agar with 5% sheep blood mold was found in the media before use.The following information was provided by the initial reporter: mold was found in the media before usage.

• Brand Name: BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
• Type of Device: SEE H.10
• 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: 16238254
• MDR Text Key: 308087658
• Report Number: 1119779-2023-00066
• Device Sequence Number: 1
• Product Code: JTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/21/2023
• Device Catalogue Number: 251801
• Device Lot Number: 2298389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 01/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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