MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CHROMAGAR® MRSA II 100MM (20 EACH); SEE H.10

Catalog Number 252353

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

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

Event Date 04/07/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd bbl¿ chromagar® mrsa ii 100mm (20 each) that there was a performance issue.The following information was provided by the initial reporter: according to the customer's report, the colony which grew after applying the patient's sample was identified as s.Aureus, even though mrsa is supposed to grow.

Manufacturer Narrative

Common device name: culture media, antimicrobial susceptibility test, excluding mueller hinton there is no 510(k) for this device as it is manufactured outside the us and not sold in the us, but it is considered to be substantially similar to the legally u.S.Marketed device bd bbl¿ chromagar® mrsa ii 100mm (20 each) , catalog number 215228 with 510k # k092767.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.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 bbl¿ chromagar® mrsa ii 100mm (20 each) that there was a performance issue.The following information was provided by the initial reporter: according to the customer's report, the colony which grew after applying the patient's sample was identified as s.Aureus, even though mrsa is supposed to grow.

Manufacturer Narrative

H.6 investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.We will continue to monitor this product.

• Brand Name: BD BBL¿ CHROMAGAR® MRSA II 100MM (20 EACH)
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16854149
• MDR Text Key: 314388808
• Report Number: 1119779-2023-00512
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 252353
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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