MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD KIESTRA INOQULA

Model Number	447202
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd kiestra inoqula false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " sample with 4 dishes processed reprocessed after a 2nd sample with 3 dishes and contaminated by 2nd sample.".
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.Medical device expiration date: na.
Additional Manufacturer Narrative
H.6 investigation summary: "the cross regional specialist reported on the bd kiestra inoqula (material # 447202 - serial # (b)(6) that a sample with 4 dishes was processed and reprocessed after a 2nd sample with 3 dishes and could be contaminated by the 2nd sample.The question was why there were 4 extra dishes added to sample.Global found in the logging that it showed that the batch was prepared with adding analysis.There was no contamination reported.Global found that the 4 extra dishes where set manually on the inoqula in the sa mode.The issue that a sample with 4 dishes was processed was confirmed by the cross regional specialist.Root cause description: user error.A review of risk management documentation indicates that the potential risk of the reported failure mode was appropriately assessed as s3 via baltrm-inoqula-aph - rev 14, id 3.38.".
Event or Problem Description
It was reported that while using bd kiestra inoqula false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " sample with 4 dishes processed reprocessed after a 2nd sample with 3 dishes and contaminated by 2nd sample.".

• Brand Name: BD KIESTRA INOQULA
• Common Device Name: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13335108
• Report Number: 1119779-2022-00095
• Device Sequence Number: 17364858
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: 00382904472023
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 10/05/2022

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 Model Number: 447202
• Device Catalogue Number: 447202
• 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: 01/04/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2015
• 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