MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD KIESTRA¿ INOQULA+¿ TLA; MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT

Model Number	447213
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that while using bd kiestra¿ inoqula+¿ tla, a specimen was synced to the incorrect patient.There was one occurrence.There was no patient impact.The following information was provided by the initial reporter: "a tech wrongly synced a specimen to different patient from the cerner.Customer said she entered an acc# in reading ¿ hit enter like normal.She cleared out the cerner mre screen, unclicked the screen sync, but didn¿t do anything different in rb.She navigated to batch reporting and noticed that the acc# that was previously up, did not go away in the top right corner.Escalating to see if this acc# being in the top right corner while the batch reporting screen is opened affected culture mb230067983.Audit log show a stool culture (not intended for batch reporting) being released as a batch report.".
Additional Manufacturer Narrative
H.6.Investigation summary: this statement is to summarize the investigation of a complaint involving the bd kiestra inoqula tla.According to the information provided, a technician had incorrectly synchronized a specimen to a different patient.During the investigation, the issue was escalated to the global service team (gst).Gst was unable to reproduce the issue.Research and development (r&d) also was unable to reproduce the issue despite multiple attempts.The proposal was to monitor the situation at the customer site and quickly re-open the investigation if the problem reoccurred.The local field service engineer (fse) monitored the system for several weeks and reported that the problem was no longer seen.Based on the investigation, this case has been assessed as confirmed for a bd quality issue.No new trends, risks, or hazards were identified as a result of this complaint.The issue in this complaint does not require the initiation of a corrective and preventative action (capa).A design history record (dhr) review is not required for this complaint.The complaint was evaluated via other elements of the investigation.Bd quality will continue to closely monitor for trends associated with this issue.
Event or Problem Description
It was reported that while using bd kiestra¿ inoqula+¿ tla, a specimen was synced to the incorrect patient.There was one occurrence.There was no patient impact.The following information was provided by the initial reporter: "a tech wrongly synced a specimen to different patient from the cerner.Customer said she entered an acc# in reading ¿ hit enter like normal.She cleared out the cerner mre screen, unclicked the screen sync, but didn¿t do anything different in rb.She navigated to batch reporting and noticed that the acc# that was previously up, did not go away in the top right corner.Escalating to see if this acc# being in the top right corner while the batch reporting screen is opened affected culture mb230067983.Audit log show a stool culture (not intended for batch reporting) being released as a batch report.".

• Brand Name: BD KIESTRA¿ INOQULA+¿ TLA
• Common Device Name: MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT
• 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: 17204942
• Report Number: 1119779-2023-00708
• Device Sequence Number: 6798726
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: 00382904472139
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: 447213
• Device Catalogue Number: 447213
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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