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

Catalog Number 443305

Device Problem Leak/Splash (1354)

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

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during centrifuge spin with the bd autocrit 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 all the tubes were broken in an autocrit centrifuge spin.

Manufacturer Narrative

H.6.Investigation: customer reported broken tubes on autocrit instrument (catalog number 420576) serial number (b)(6).The customer indicated sureprep capillary tubes were leaking in the centrifuge during a spin.After further investigation it was determined, the issues was attributed to improper workflow by user.Customer communicated that after following the correct workflow there is no issue with the centrifuge.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.Root cause is attributed to user error.This complaint is not a confirmed failure of the instrument based in the customer response.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.¿.

Event Description

It was reported that during centrifuge spin with the bd autocrit 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 all the tubes were broken in an autocrit centrifuge spin.

• Brand Name: BD AUTOCRIT
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12836770
• MDR Text Key: 284835866
• Report Number: 1119779-2021-01846
• Device Sequence Number: 1
• Product Code: GKG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 443305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• 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