MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE CHROMAGAR ORIENTATION 20 EA

Catalog Number 251781

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

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

It was reported that while using the plate chromagar orientation 20 ea thata there was a performance issue.The following information was provided by the initial reporter: according to the customer's report, a colony blue in color that grew in the plate chromagar orientation was identified as e-coli (also by a mass spectrometer), although in the catalog it was described as purple color.

Manufacturer Narrative

D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.G5.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¿ orientation agar, catalog number 215081 with 510k #exempt.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary : material #: 251781.Lot/batch #: unknown.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.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that while using the plate chromagar orientation 20 ea thata there was a performance issue.The following information was provided by the initial reporter: according to the customer's report, a colony blue in color that grew in the plate chromagar orientation was identified as e-coli (also by a mass spectrometer), althogh in the catalog it was desribed as purple color.

• Brand Name: PLATE CHROMAGAR ORIENTATION 20 EA
• Type of Device: NA
• 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: 16770435
• MDR Text Key: 313816262
• Report Number: 1119779-2023-00446
• Device Sequence Number: 1
• Product Code: JSH
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 251781
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• 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