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

Model Number 447213

Device Problem Structural Problem (2506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 296044574
• Report Number: 3010141591-2022-00011
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: 00382904472139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 447213
• Device Catalogue Number: 447213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention