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

Model Number	447202
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported bd (b)(4) had an issue with the barcoda lid falling.The following information was provided by the initial reporter: "the customer reports the cover for the barcoda printer slams shut.".
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary: "the customer reported on the bd kiestra inoqula (material # 447202 - serial # (b)(6)) that the cover for the barcoda printer slams shut.The field service engineer verified that the lid covering the barcoda printer was slamming shut and replaced the gas springs.The field service engineer verified the instrument operation and instrument was released for customer routine use.Corrective and preventive action (capa) and situation analysis (sa) have been opened for the investigation of the potential gap in implementation of corrective actions leading to increased risks of user injury after complaints were received describing issues with dropping barcoda hood.This complaint has been included in the capa for traceability of the issue.The issue that the cover for the barcoda printer slams shut was confirmed by the field service engineer.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." h3 other text : other.
Event or Problem Description
It was reported bd kiestra¿ inoqula+¿ had an issue with the barcoda lid falling.The following information was provided by the initial reporter: "the customer reports the cover for the barcoda printer slams shut.".

• Brand Name: BD KIESTRA¿ INOQULA+¿
• Common Device Name: 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: 13895693
• Report Number: 3010141591-2022-00004
• Device Sequence Number: 17162533
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: 00382904472023
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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
• Operator of Device: Other
• Device Model Number: 447202
• Device Catalogue Number: 447202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown