MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) UNSPECIFIED BD CENTRIFUGE; UNKNOWN

Catalog Number 420556

Device Problem Unintended Movement (3026)

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

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore bd corporate sparks, md has been listed and bd.Sparks, md fda registration number has been used for the manufacture number.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 while using a unspecified bd centrifuge several issues have occurred.It may not stop spinning, the timer finishes before the time is up.While inspecting the unit it felt warm and notice a faint burn smell.No injuries were reported.The following information was provided by the initial reporter: customer states that unit has several issues.It may not stop spinning after is up, the timer finishes before the time should be up.While inspecting the unit, the biomed noticed the plate inside the unit felt warmer than normal and he noticed a faint electrical burnt smell.Unit has not been in use.No injuries to report.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2023-00546 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.H3 other text : see h.10.

Event Description

It was reported that while using a unspecified bd centrifuge several issues have occurred.It may not stop spinning, the timer finishes before the time is up.While inspecting the unit it felt warm and notice a faint burn smell.No injuries were reported.The following information was provided by the initial reporter: customer states that unit has several issues.It may not stop spinning after is up, the timer finishes before the time should be up.While inspecting the unit, the biomed noticed the plate inside the unit felt warmer than normal and he noticed a faint electrical burnt smell.Unit has not been in use.No injuries to report.

• Brand Name: UNSPECIFIED BD CENTRIFUGE
• Type of Device: UNKNOWN
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16916154
• MDR Text Key: 315080632
• Report Number: 1119779-2023-00546
• Device Sequence Number: 1
• Product Code: GKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 420556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• 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