MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD TRIAC¿ CENTRIFUGE; SEE H.10

Catalog Number 420200

Device Problem Break (1069)

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

Event Date 07/05/2022

Event Type  malfunction  

Event Description

It was reported that during centrifuge spin with the bd triac¿ centrifuge the tubes are breaking.This occurred on 8 separate occasions.There was no user impact and there was no report of patient impact.The following information was provided by the initial reporter: customer reported that multiple tubes of blood have been broken at different times during the spinning process.

Manufacturer Narrative

Medical device expiration date: unknown.Common device name: equipment, laboratory, general purpose, labeled and promoted for a specific medical use.Device manufacture date: unknown.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 during centrifuge spin with the bd triac¿ centrifuge the tubes are breaking.This occurred on 8 separate occasions.There was no user impact and there was no report of patient impact.The following information was provided by the initial reporter: customer reported that multiple tubes of blood have been broken at different times during the spinning process.

Manufacturer Narrative

Updated the new event date.H.6 investigation summary customer reported broken tubes on triac instrument (catalog number 420200) serial number (b)(6).The customer indicated multiple tubes have been broken at different times during the spinning process.Customer indicated no reports of injury or exposure to blood/bodily fluids.Centrifuge was taken out of service.Informed customer the product is discontinued, and no spare parts are available.Root cause is not determined, and this complaint is not a confirmed failure of the instrument as the instrument was not returned to investigate.Review of device history record for instrument serial number, (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed for the instrument (b)(6), and no additional work orders were observed for the complaint failure mode reported.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to closely monitor trends associated with the failure of ¿safety.¿ capa is not required as no trends were identified.Complaint history for "safety" was reviewed for the month of august 2022.The upper control limit was not breached, and trends were not identified associated with this defect.Review of risk management documentation indicates that the potential risk of the reported failure mode was assessed as severity s4, operator is exposed to potentially harmful and infectious materials via document (b)(4), revision 01, row id 10.0.

• Brand Name: BD TRIAC¿ CENTRIFUGE
• Type of Device: SEE H.10
• 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: 15225099
• MDR Text Key: 305273427
• Report Number: 1119779-2022-01106
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

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: 420200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/23/2022
• 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