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 12/01/2022

Event Type  malfunction  

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 springs needed to be replaced.Lid was reported to have fallen down.No injuries were reported.The following information was provided by the initial reporter: did the barcoda lid fall down or slam? yes.

Event Description

It was reported that bd kiestra inoqula gas springs needed to be replaced.Lid was reported to have fallen down.No injuries were reported.The following information was provided by the initial reporter: did the barcoda lid fall down or slam? yes.

Manufacturer Narrative

H.6 investigation summary: the customer care engineer (cce) reported on the bd kiestra inoqula (material # 447202 - serial # (b)(6)) that the cylinders of the rear cover of the fa module and of the cover on the barcoda module were defective.The cce replaced the cylinders.After the cylinders were replaced, the instrument operated within the instrument specifications and is ready for routine use without restrictions.The issue that the cylinders were defective was confirmed by the customer care engineer.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.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: 16109008
• MDR Text Key: 306897352
• Report Number: 1119779-2023-00001
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: 00382904472023
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• 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: 06/01/2023

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 Model Number: 447202
• Device Catalogue Number: 447202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2023
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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