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	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that the bd kiestra inoqula has been found producing a false negative result.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 ; +1(410)316-4000
• MDR Report Key: 50409246
• Report Number: 3010141591-2026-00009
• Device Sequence Number: 18441742
• Product Code: JTC
• UDI-Device Identifier: 00382904469733
• UDI-Public: (01)00382904469733(11)220309
• Combination Product (Y/N): N
• Initial Reporter Country: RE
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2022
• 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: Other
• Patient Sex: Unknown