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 Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2021

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.(b)(4).

Event Description

It was reported that after pms were performed with bd bactec¿ fx, instrument top, packaged several bottles were flagged as false positive.There was no report of confirmatory testing or patient impact.

Manufacturer Narrative

H6: investigation summary: customer reported false positive issue on a bd bactec fx top instrument (p/n 441385, s/n (b)(6).No erroneous results were reported to doctors, and patients were not impacted.Bd remote assistance communicated with the customer and received the log files and plot.The fse reviewed the plot.The plot revealed not enough information provided to investigate the possible false positives.Documented procedures have been shared with field service engineers in case similar situation would appear again at a customer.This is an unconfirmed failure of the bd product.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.The root cause was unable to be determined.No new trends, risks, or hazards were identified as a result of the complaint.H3 other text : see h10.

Event Description

It was reported that after pms were performed with bd bactec¿ fx, instrument top, packaged several bottles were flagged as false positive.There was no report of confirmatory testing or 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: 11386716
• MDR Text Key: 242644210
• Report Number: 1119779-2021-00401
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1