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

Model Number 447213

Device Problem Structural Problem (2506)

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

Event Date 06/21/2022

Event Type  malfunction  

Event Description

It was reported by the customer that the bd kiestra¿ inoqula+¿ tla gas springs needed to be replaced.Minor injury was reported.The following information was provided by the initial reporter: the gas springs would hold the lid up as long as it was open all the way.If the lid was not opened past the half way point it would fall on its own.The user that had the lid fall on her hand told me the lid was not opened all the way.

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 by the customer that the bd kiestra¿ inoqula+¿ tla gas springs needed to be replaced.Minor injury was reported.The following information was provided by the initial reporter: the gas springs would hold the lid up as long as it was open all the way.If the lid was not opened past the half way point it would fall on its own.The user that had the lid fall on her hand told me the lid was not opened all the way.

Manufacturer Narrative

Mdr should be considered canceled because the issue was captured in mfr # 3010141591-2022-00011.

• Brand Name: BD KIESTRA¿ INOQULA+¿ TLA
• Type of Device: MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT
• 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: 14961815
• MDR Text Key: 302841498
• Report Number: 3010141591-2022-00010
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: 00382904472139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• 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: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2018
• 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