MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD KIESTRA INOQULA

Catalog Number 447204

Device Problem Structural Problem (2506)

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

Event Date 05/24/2022

Event Type  malfunction  

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 that while using bd kiestra inoqula the lid would not stay open and was falling on its own.There was no user impact.The following information was provided by the initial reporter; "ino - gas spring.Problem with the 2 pneumatic cylinders of the cover of the barcoda which fall back on their own.".

Event Description

It was reported that while using bd kiestra inoqula the lid would not stay open and was falling on its own.There was no user impact.The following information was provided by the initial reporter; "ino - gas spring problem with the 2 pneumatic cylinders of the cover of the barcoda which fall back on their own.".

Manufacturer Narrative

H.6 investigation summary: "the field service engineer reported on the instrument bd kiestra inoqula wca (material # 447204 - serial # (b)(6)) that there was a problem with the two pneumatic cylinders of the cover of the barcoda, which fall back on their own.The field service engineer replaced the two pneumatic cylinders on the barcoda cover (ref: (b)(4)).The instrument was left fully operational.The issue that two pneumatic cylinders of the barcoda cover were worn was confirmed by the field service engineer.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.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 : see h.10.

• Brand Name: BD KIESTRA INOQULA
• Type of Device: NA
• 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: 14758372
• MDR Text Key: 302594020
• Report Number: 1119779-2022-00919
• Device Sequence Number: 1
• Product Code: JTC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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: 06/29/2022

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: Other
• Device Catalogue Number: 447204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2017
• 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