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 10/31/2022

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.

Event Description

It was reported that bd kiestra inoqula lid not holding up properly.The following information was provided by the initial reporter: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details we need more info regarding this pr.Did the lid fall off? if so it changed reportability.The lid did not fall off, but the gas spring does not hold it properly, hence the case to replace this parts.This issue was noticed during preventive maintenance.

Event Description

It was reported that bd kiestra inoqula lid not holding up properly.The following information was provided by the initial reporter: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.We need more info regarding this pr.Did the lid fall off? if so it changed reportability.The lid did not fall off, but the gas spring does not hold it properly, hence the case to replace this parts.This issue was noticed during preventive maintenance.

Manufacturer Narrative

H.6 investigation summary: bd technical services reported a worn-out gas spring on instrument bd kiestra (material: 447202, serial number:(b)(6) ).Springs were replaced with new set which has confirmed the complaint.Root cause is defined as faulty springs, and replacement with new set is initiated as a corrective action.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.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: 15826423
• MDR Text Key: 307087315
• Report Number: 1119779-2022-01402
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: 00382904472023
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NA
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• 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: 02/01/2023
• 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