MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA¿ INOQULA+¿; MICROTITER DILUTING/DISPENSING DEVICE

Model Number	447202
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd kiestra¿ inoqula+¿ had an issue with the barcoda lid falling.The following information was provided by the initial reporter: "door above printer falls down".
Event or Problem Description
It was reported that bd kiestra¿ inoqula+¿ had an issue with the barcoda lid falling.The following information was provided by the initial reporter: "door above printer falls down".
Additional Manufacturer Narrative
H.6 investigation summary: it was reported on the bd kiestra inoqula that the door above the printer falls down.The field service engineer visited the customer and replaced the gas springs, holding the barcoda hood.The issue that the door above the printer fell down was confirmed by the field service engineer.Further analyses tasks have been opened for the investigation of corrective actions leading to avoid risks of errors and user injury.Design history record (dhr) review is not required for this complaint as further analysis is underway.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+¿
• Common Device Name: MICROTITER DILUTING/DISPENSING DEVICE
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13971685
• Report Number: 3010141591-2022-00006
• Device Sequence Number: 4476731
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: 00382904472023
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/20/2022

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: 447202
• Device Catalogue Number: 447202
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2019
• 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