MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ CHROMAGAR® MRSA II 100MM (20 EACH); CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON

Catalog Number 252353

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

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

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is fukushima.This site is an oem manufacturing site.Therefore, bd corporate headquarters 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 d.4.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.

Event Description

It was reported that while using bd bbl¿ chromagar® mrsa ii 100mm (20 each) there was insufficient growth of one sample.No patient impact reported.The following information was provided by the initial reporter: "this is a report about an issue that mrsa does not grow from the sample.According to the customer's report, the bacteria which result was positive by blood cultivation and identified as mrsa by maldi does not grow.It slightly grows when spreading the sample on the blood agar, making an isolation culture, and spreading on the mrsa media.Were these patient samples? yes.- if so - were any erroneous results reported to healthcare provider? no.- if yes - were any patients treated based on the erroneous results? na.- any other patient impact >>no patient impact".

Event Description

It was reported that while using bd bbl¿ chromagar® mrsa ii 100mm (20 each) there was insufficient growth of one sample.No patient impact reported.The following information was provided by the initial reporter: "this is a report about an issue that mrsa does not grow from the sample.According to the customer's report, the bacteria which result was positive by blood cultivation and identified as mrsa by maldi does not grow.It slightly grows when spreading the sample on the blood agar, making an isolation culture, and spreading on the mrsa media.Were these patient samples? yes.If so - were any erroneous results reported to healthcare provider? no.If yes - were any patients treated based on the erroneous results? na.Any other patient impact no patient impact.".

Manufacturer Narrative

H.6.Investigation summary: 252353 #3185591 we couldn't confirm this issue as a report because no photo and returned sample.No issue in retention for performance and dhr.No trend.We will continue to monitor this lot.

• Brand Name: BD BBL¿ CHROMAGAR® MRSA II 100MM (20 EACH)
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17839467
• MDR Text Key: 324530994
• Report Number: 1119779-2023-01035
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092767
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 252353
• Device Lot Number: 3185591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2023
• 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