MAUDE Adverse Event Report: KIESTRA LAB AUTOMATION BD KIESTRA INOQULA TLA; SEE H.10

Model Number	447213
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: equipment, laboratory, general purpose, labeled and promoted for a specific medical use.Medical device expiration date: na.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 the bd kiestra inoqula tla- barcoda lid came down on tech finger.Technician reports that a lab tech had the barcoda lid come down on their finger.The tech went to the emergency room and had x-rays.No broken bone found.No blood reported, tech has a small bruise, a band-aid was given.
Event or Problem Description
It was reported that the bd kiestra inoqula tla- barcoda lid came down on tech finger technician reports that a lab tech had the barcoda lid come down on their finger.The tech went to the emergency room and had x-rays.No broken bone found.No blood reported, tech has a small bruise, a band-aid was given.
Additional Manufacturer Narrative
H 6.Investigation summary: the field service engineer reported that the cover of the barcoda module on the instrument bd kiestra inoqula tla (material #447213, serial number (b)(6)) fell down on lab technicians hand causing an injury.Issue was confirmed by bd.The field service engineer replaced the two pneumatic cylinders on the barcoda cover to assure proper hold.The instrument was left fully operational.Bd has issued a corrective and preventive action (capa) to investigate the issue further.Design history record (dhr) review is not required for this complaint.The complaint was evaluated via other elements of the investigation.

• Brand Name: BD KIESTRA INOQULA TLA
• Common Device Name: SEE H.10
• Manufacturer (Section D): KIESTRA LAB AUTOMATION; marconilaan 6; jc drachten NL - 9207; NL NL - 9207
• 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: 15033486
• Report Number: 3010141591-2022-00011
• Device Sequence Number: 5102368
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: 00382904472139
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown