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

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 while using bd bactec¿ fx, instrument top, packaged false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

Event Description

It was reported that while using bd bactec¿ fx, instrument top, packaged false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

H6: investigation summary: customer reported issue on a bd bactec fx top instrument (p/n 441385, s/n (b)(6)).Customer indicated that the instrument had several false positives after preventative maintenance.No erroneous results were reported to doctors, and patients were not impacted.Due to the lack of information provided to investigate the possible false positives which appeared after preventative maintenance.Documented procedures have been shared the field service engineer in case similar situation would appear again at a customer.This case will be re-opened and re-investigated if any additional information is received in the future.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.

• 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: 11382084
• MDR Text Key: 247025775
• Report Number: 1119779-2021-00394
• 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: 04/29/2021

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: 02/25/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1