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

Model Number 447202

Device Problem Structural Problem (2506)

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

Event Date 03/08/2023

Event Type  malfunction  

Event Description

It was reported that bd kiestra inoqula gas spring on small inner hood for barcoda printer barely holding up the hood.No injuries were reported.The following information was provided by the initial reporter: fse noticed the gas spring for the small hood cover of the barcoda printer is barely holding the hood up.

Manufacturer Narrative

Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd kiestra inoqula gas spring on small inner hood for barcoda printer barely holding up the hood.No injuries were reported.The following information was provided by the initial reporter: fse noticed the gas spring for the small hood cover of the barcoda printer is barely holding the hood up.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2023-00399 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16678744
• MDR Text Key: 312797438
• Report Number: 1119779-2023-00399
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: 00382904472023
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 447202
• Device Catalogue Number: 447202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2015
• 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