MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD KIESTRA¿ INOQULA+¿ TLA; MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT

Model Number 447213

Device Problem False Negative Result (1225)

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

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter email: (b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd kiestra¿ inoqula+¿ tla machine error cause patients to be retested due to possible discrepancy in results.The following information was provided by the initial reporter: lab technologist was looking at the inoqula while it was inoculating a bi-plate.Instead of dispensing an inoculum on each side of the bi-plate, the inoqula dispensed the sample twice on the same side.The two beads were delivered on each side and the streaking happened as expected even though only one side of the bi-plate contained sample inoculum.All that without giving an error or alarm.Only few patients were re-tested but no comparison was made to identify if there was a discrepancy with previous results.

Manufacturer Narrative

H.6 investigation summary the customer reported on the bd kiestra inoqula tla (material number: 447213 serial number: (b)(6) that wrong inoculation of bi-plates.The field service (fse) engineer was dispatched to fix the issue.The fse observed the issue and adjusted the inoculation of bi-plate and ran the samples.Thus, resolving the issue and the instrument is working properly as per specifications.This is the confirmed complaint of the bd product.Dhr review is not required for this complaint.The complaint was evaluated via other elements of the investigation.The results of this evaluation have not identified any new hazards, new risks, or specific trends.No parts or materials were returned as a part of this complaint.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this complaint.H3 other text : see h.10.

Event Description

It was reported that bd kiestra¿ inoqula+¿ tla machine error cause patients to be retested due to possible discrepancy in results.The following information was provided by the initial reporter: lab technologist was looking at the inoqula while it was inoculating a bi-plate.Instead of dispensing an inoculum on each side of the bi-plate, the inoqula dispensed the sample twice on the same side.The two beads were delivered on each side and the streaking happened as expected even though only one side of the bi-plate contained sample inoculum.All that without giving an error or alarm.Only few patients were re-tested but no comparison was made to identify if there was a discrepancy with previous results.

• Brand Name: BD KIESTRA¿ INOQULA+¿ TLA
• Type of Device: MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16704558
• MDR Text Key: 312951761
• Report Number: 1119779-2023-00405
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: 00382904472139
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• 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: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• 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