MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA¿ INOQULA+¿ TLA; MICROBIAL SPECIMEN INOCULATION

Model Number 447213

Device Problem Structural Problem (2506)

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

Event Date 06/22/2022

Event Type  malfunction  

Event Description

It was reported that while using bd kiestra¿ inoqula+¿ tla the barcoda lid fell.There was no report of impact.The following information was provided by the initial reporter: "it was reported by the customer that hood gas springs need replacement.".

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.

Event Description

It was reported that while using bd kiestra¿ inoqula+¿ tla the barcoda lid fell.There was no report of impact.The following information was provided by the initial reporter: " it was reported by the customer that hood gas springs need replacement.".

Manufacturer Narrative

H6 investigation summary : the customer reported on the bd kiestra inoqula tla (material # 447213 - serial # (b)(6).That the hood gas springs needed replacement.The barcoda hood did not stay open.The field service engineer first swapped the hood gas springs from the barcoda 2 to the barcoda 1 until the new springs arrived.The new gas springs (material number 446064) were installed and tested without issues found.A capa 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 gas springs needed replacement was confirmed by the field service engineer.Bd has initiated further root cause investigation related to barcoda lid fall through corrective and preventative actions to avoid risks of errors and user injury.This complaint has been included in the capa 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.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.

• Brand Name: BD KIESTRA¿ INOQULA+¿ TLA
• Type of Device: MICROBIAL SPECIMEN INOCULATION
• 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: 14808398
• MDR Text Key: 303260052
• Report Number: 3010141591-2022-00009
• 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: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• 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: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2018
• 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