MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA¿ INOQULA+¿ TLA; MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT

Catalog Number	447213
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Additional phone #: (b)(6).H3.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 during use with the bd kiestra¿ inoqula+¿ tla, the barcoda hood fell.There was no report of patient impact.
Event or Problem Description
It was reported that during use with the bd kiestra¿ inoqula+¿ tla, the barcoda hood fell.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: this statement is to summarize the investigation of a complaint involving the bd kiestra inoqula tla.According to the information provided, it was reported that the fa hood gas springs needed replacement.During the investigation, the automation service engineer (ase) discovered that the hood would descend on its own.The ase replaced the gas springs.Following the replacement, the instrument was returned to the customer and functioned as expected.Following this action, no further issues were encountered.Based on the investigation, this case has been assessed as confirmed for a bd quality issue.A corrective and preventive actions (capa) and situation analysis (sa) have been opened for the investigation to avoid risks of user injury after complaints were received describing issues with the barcoda hood dropping.This complaint has been included in the capa for traceability of the issue.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.

• Brand Name: BD KIESTRA¿ INOQULA+¿ TLA
• Common Device Name: MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten ; NL
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten ; NL
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19484643
• Report Number: 3010141591-2024-00006
• Device Sequence Number: 18226669
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: (01)00382904472139
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 05/09/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2018
• 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
• Patient Sex: Unknown