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

Catalog Number 420200

Device Problem Leak/Splash (1354)

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

Event Date 07/08/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Device manufacture date: unknown.Common device name :equipment, laboratory, general purpose, labeled and promoted for a specific medical use.

Event Description

It was reported that while using bd triac¿ centrifuge multiple tubes of blood have been broken at different times.The following information was provided by the initial reporter multiple tubes of blood have been broken at different times during the spinning process, regardless of the tubes being balanced.

Event Description

It was reported that while using bd triac¿ centrifuge multiple tubes of blood have been broken at different times.The following information was provided by the initial reporter multiple tubes of blood have been broken at different times during the spinning process, regardless of the tubes being balanced.

Manufacturer Narrative

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.¿.

• 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: 15316996
• MDR Text Key: 305347512
• Report Number: 1119779-2022-01136
• 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

• Date FDA Received: 08/29/2022
• 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
• Date Manufacturer Received: 12/02/2022
• 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