MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD EPICENTER¿ SINGLE USER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number	441007
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd epicenter¿ single user software acquired mis-association due to use error.The following information was provided by the initial reporter: "wrong acceptance of samples clear problem/ epicenter failure: no.Cause of epicenter failure: external error.Resolution of the failure/ what was done to resolve the epicenter failure: the nurse who performed the sampling reversed the access number labels on the bactec bottles by entering the reservation of the aerobic blood culture on the anaerobic bottle and the acceptance of the anaerobic blood culture on the aerobic bottle.Has reversed the access number labels on the bactec bottles by inserting the reservation of the aerobic blood culture on the anaerobic bottle and the acceptance of the anaerobic blood culture on the aerobic bottle.Solved by explaining to the customer how to associate the right sample with the right bottle.Verified with the customer passage of the resistance markers and notes to the report.Checked for correct operation.Incorrect labeling by nurses of blood culture sampling.".
Additional Manufacturer Narrative
Initial reporter phone#: (b)(6).Initial reporter fax#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: this is not a confirmed complaint of a bd product.Per baltrm-441007-aph revision 5, the failure associated to this complaint is a user inconvenience which is a severity of s1; reference id 6.3.Complaints for software were under statistical control for the month of may.No trends indicated.Device history record review is not required for standalone software.Complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
It was reported that the bd epicenter¿ single user software acquired mis-association due to use error.The following information was provided by the initial reporter: "wrong acceptance of samples.Clear problem/ epicenter failure: no.Cause of epicenter failure: external error.Resolution of the failure/ what was done to resolve the epicenter failure: the nurse who performed the sampling reversed the access number labels on the bactec bottles by entering the reservation of the aerobic blood culture on the anaerobic bottle and the acceptance of the anaerobic blood culture on the aerobic bottle.Has reversed the access number labels on the bactec bottles by inserting the reservation of the aerobic blood culture on the anaerobic bottle and the acceptance of the anaerobic blood culture on the aerobic bottle.Solved by explaining to the customer how to associate the right sample with the right bottle.Verified with the customer passage of the resistance markers and notes to the report.Checked for correct operation incorrect labeling by nurses of blood culture sampling".

• Brand Name: BD EPICENTER¿ SINGLE USER SOFTWARE
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• 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: 14628481
• Report Number: 1119779-2022-00832
• Device Sequence Number: 6113724
• Product Code: JQP
• UDI-Device Identifier: 00382904410070
• UDI-Public: 00382904410070
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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
• Operator of Device: Other
• Device Model Number: 441007
• Device Catalogue Number: 444165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown