MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC FX, INSTRUMENT TOP, PACKAGED; SYSTEM, BLOOD CULTURING

Model Number 441385

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2020

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.(b)(4).

Event Description

It was reported that the bd bactec¿ fx, instrument top, packaged flagged approximately 11 false positive files over a short period of time.The customer performed gram stains and the results were negative.There was no indication that results were reported out or any report of patient impact.

Manufacturer Narrative

H6: investigation summary customer reported false positive issue on a bd bactec fx top instrument (p/n 441385, s/n ft9676).No erroneous results were reported to doctors, and patients were not impacted.Customer indicated that 11 false positives occurred over a short period of time.A bd field service engineer (fse) was dispatched and unable to duplicate the issue, uploaded logfiles to q drive for review.The instrument remains in operation.Review of the device history record is not required due to the age of the instrument.Service history record review revealed no previous complaints for this issue.Bd quality did not receive any returned parts or instrument for investigation.This complaint is a confirmed failure of a bd product.The root cause is power supply voltages and drawer control board.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this failure.See h10.

Event Description

It was reported that the bd bactec¿ fx, instrument top, packaged flagged approximately 11 false positive files over a short period of time.The customer performed gram stains and the results were negative.There was no indication that results were reported out or any report of patient impact.

• Brand Name: BD BACTEC FX, INSTRUMENT TOP, PACKAGED
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11205668
• MDR Text Key: 228017409
• Report Number: 1119779-2021-00113
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: 00382904413859
• Combination Product (y/n): N
• PMA/PMN Number: K915796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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: 441385
• Device Catalogue Number: 441385
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1