MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD KIESTRA INOQULA; DEVICE, MICROTITER DILUTING/DISPENSING

Model Number	447202
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional 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: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported while testing with bd kiestra inoqula the barcoda lid fell.There was no report of patient impact.The following information was provided by the initial reporter: gas hood springs barcoda defective the gas springs did not hold the lid.But the problem has been fixed.The gas springs have been replaced.
Additional Manufacturer Narrative
H.8: "it was reported on the bd kiestra inoqula (material # 447202 - serial # (b)(6) that during preventive maintenance (preventive maintenance case 01637847) it was found that the gas hood springs off the barcoda were defective.The two gas springs were replaced during the preventive maintenance.Capa# 5284707 and situation analyses (b)(4) 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 capa# 5284707 for traceability of the issue.The issue that the gas hood springs off the barcoda were defective was confirmed by the preventive maintenance field service engineer.Root cause description: gas hood springs barcoda defective.A review of risk management documentation indicates that the potential risk of the reported failure mode was appropriately assessed as s3 via baltrm-inoqula-aph - rev 14, id 2.22".
Event or Problem Description
It was reported while testing with bd kiestra inoqula the barcoda lid fell.There was no report of patient impact.The following information was provided by the initial reporter: gas hood springs barcoda defective the gas springs did not hold the lid.But the problem has been fixed.The gas springs have been replaced.

• Brand Name: BD KIESTRA INOQULA
• Common Device Name: DEVICE, MICROTITER DILUTING/DISPENSING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14459343
• Report Number: 1119779-2022-00735
• Device Sequence Number: 4569794
• 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): 06/21/2022

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: Health Professional
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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