MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA¿ INOQULA+¿; MICROTITER DILUTING/DISPENSING DEVICE

Catalog Number 447204

Device Problem Structural Problem (2506)

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

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using bd kiestra¿ inoqula+¿ the lid was not held up.There was no customer impact.The following information was provided by the initial reporter, translated from french to english: hood cylinder no longer hold.Comments: situation on arrival/current situation: functional barcoda / functional barcoda.Action taken on the original issue: replacement of the jacks that hold the cover above the printer.Software version: barcoda v26.0.1.Cause of the problem: the hood of the barcoda no longer holds.

Manufacturer Narrative

H6: investigation summary the customer care engineer reported on the instrument bd kiestra inoqula wca (material # 447204 - serial # (b)(6)) that the hood of the barcoda no longer holds.The customer care engineer replaced the jacks that hold the cover above the printer.Corrective and preventive action (capa) 5284707 and situation analyses have been opened for the investigation of corrective actions leading to avoid risks of errors and user injury.The issue that the hood of the barcoda no longer holds was confirmed by the customer care engineer.This complaint has been included in capa 5284707 for traceability of the issue.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.

Event Description

It was reported that while using bd kiestra¿ inoqula+¿ the lid was not held up.There was no customer impact.The following information was provided by the initial reporter, translated from french to english: "hood cylinder no longer hold.Comments: 1.Situation on arrival/current situation: functional barcoda / functional barcoda.2.Action taken on the original issue: replacement of the jacks that hold the cover above the printer.3.Software version: barcoda v26.0.1 4.Cause of the problem: the hood of the barcoda no longer holds.".

• Brand Name: BD KIESTRA¿ INOQULA+¿
• Type of Device: MICROTITER DILUTING/DISPENSING DEVICE
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14635357
• MDR Text Key: 301241870
• Report Number: 3010141591-2022-00008
• Device Sequence Number: 1
• Product Code: JTC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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: 06/16/2022

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
• Device Operator: Other
• Device Catalogue Number: 447204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• 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