MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SAMPLE PREP ASSISTANT III; AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS

Model Number 647205

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd facs¿ sample prep assistant iii had foreign matter in the sample line.The following information was provided by the initial reporter: "bd facs¿ sample prep assistant iii.(b)(6).The equipment is contaminating the antibodies with blood during pipetting.".

Manufacturer Narrative

Additional information has been received that showed that this complaint is not reportable.The mdr for this complaint should be considered cancelled.

Event Description

It was reported that bd facs¿ sample prep assistant iii had foreign matter in the sample line.The following information was provided by the initial reporter: "bd facs¿ sample prep assistant iii.Edione reis: (b)(6) 2020, 19:42:43 (gmt) the equipment is contaminating the antibodies with blood during pipetting.".

• Brand Name: BD FACS SAMPLE PREP ASSISTANT III
• Type of Device: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11070604
• MDR Text Key: 241732159
• Report Number: 2916837-2020-00325
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

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 Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 11/27/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1