MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA INOQULA; MICROBIAL SPECIMEN INOC/STREAKING INSTRUMENT

Catalog Number	446973
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that the bd kiestra inoqula has been found producing incorrect results for an unspecified number of patient urine samples.No patient impact was reported.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

• Brand Name: BD KIESTRA INOQULA
• Common Device Name: MICROBIAL SPECIMEN INOC/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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 25034193
• Report Number: 3010141591-2026-00004
• Device Sequence Number: 18401978
• Product Code: JTC
• UDI-Device Identifier: 00382904469733
• UDI-Public: (01)00382904469733(11)251212
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: 446973
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2025
• 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