MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA INOQULA; UNKNOWN

Model Number 447202

Device Problem Structural Problem (2506)

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

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.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 while using the bd kiestra inoqula the hood does not stay in the up position.No patient impact was reported.The following information was provided by the initial reporter: the hood of the barcoda does not stay in the up position.

Manufacturer Narrative

H.6 investigation summary: customer reported barcoda lid not staying in place on instrument bd kiestra inoqula (material: 447202, serial number:(b)(6)).Bd technical services have confirmed the complaint by checking the gas springs holding the lid open.They have replaced gas springs with a new set which has solved the issue.This is a known issue investigated under situation analyses and corrective and preventative action (capa).Root cause is defined as faulty springs, and replacement with new set is initiated as a corrective action.Design history record (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.Bd quality will continue to closely monitor for trends associated with this issue.

Event Description

It was reported that while using the bd kiestra inoqula the hood does not stay in the up position.No patient impact was reported.The following information was provided by the initial reporter: the hood of the barcoda does not stay in the up position.

• Brand Name: BD KIESTRA INOQULA
• Type of Device: UNKNOWN
• 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: 15626830
• MDR Text Key: 307063093
• Report Number: 3010141591-2022-00014
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: 00382904472023
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 447202
• Device Catalogue Number: 447202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2018
• 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