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

Model Number 447202

Device Problem Structural Problem (2506)

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

Event Date 04/21/2022

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 292216861
• Report Number: 1119779-2022-00735
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: 00382904472023
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 447202
• Device Catalogue Number: 447202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1