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

Model Number	447202
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the printer lid on bd kiestra¿ inoqula+¿ was falling.There was no patient impact.The following information was provided by the initial reporter, translated from german to english: "the cover on the printer falls off sporadically.".
Additional Manufacturer Narrative
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 field service engineer reported on the bd kiestra inoqula (material # 447202 - serial # (b)(6).) that the cover on the printer falls off sporadically.The dampers need to be replaced.The product technical specialist replaced the dampers (spare part 5000-555-10).The dampers were defective, and the lid lowered automatically.Corrective and preventive action (capa) and situation analysis (sa) have been opened for the investigation of corrective actions leading to avoid risks of errors and user injury.The issue that the cover on the printer falls off sporadically was confirmed by the field service engineer.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.".
Event or Problem Description
It was reported the printer lid on bd kiestra¿ inoqula+¿ was falling.There was no patient impact.The following information was provided by the initial reporter, translated from german to english: "the cover on the printer falls off sporadically.".

• 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: 13934915
• Report Number: 3010141591-2022-00005
• Device Sequence Number: 4590511
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: 00382904472023
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: 03/08/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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