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

Catalog Number	447213
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd kiestra inoqula tla, the printer was found with a flame coming out of it.No adverse impact was reported regarding the patient or user.The following has been provided by the initial reporter: printer connected to workbench 2.4 suddenly had a flame coming out of it.The fire originated from the power cord.The fire died out of its own and did not cause any damage or injuries, except to the printer itself.
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 while using the bd kiestra inoqula tla, the printer was found with a flame coming out of it.No adverse impact was reported regarding the patient or user.The following has been provided by the initial reporter: printer connected to workbench 2.4 suddenly had a flame coming out of it.The fire originated from the power cord.The fire died out of its own and did not cause any damage or injuries, except to the printer itself.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.4 udi#: (b)(4).Investigation summary: this statement is to summarize the investigation of a complaint involving the bd kiestra inoqula tla.According to the information provided, the customer reported that a printer connected to workbench 2.4 suddenly had a flame coming out of it.During the investigation, it was found that the printer had caught fire.There was a potential danger due to the fire originating from the printer¿s power cord.However, the fire extinguished itself quickly and did not cause any damage or injuries, except to the printer itself.The situation was promptly addressed by replacing the faulty printer, ensuring no further risk.The customers local it and electricians replaced the cables and removed the faulty printer.The customer care engineer (cce) ordered and installed a new printer.Following this action, no further issues were encountered.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.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Bd quality will continue to closely monitor for trends associated with this issue.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20137754
• Report Number: 1119779-2024-00660
• Device Sequence Number: 7482814
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: (01)00382904472139(11)161222
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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 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: 08/19/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2016
• 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