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 01/31/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Initial reporter phone #: (b)(6).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 while testing with bd bactec¿; fx, instrument top, packaged false positive results were obtained.There was no report if repeat or confirmatory testing was performed.There was no report of patient impact.

Manufacturer Narrative

The following fields has been updated with corrected information: b.3.Date of event: (b)(6) 2021.

Event Description

It was reported while testing with bd bactec¿; fx, instrument top, packaged false positive results were obtained.There was no report if repeat or confirmatory testing was performed.There was no report of patient impact.

Manufacturer Narrative

H.6.Investigation: customer reported more than 21 samples has been given false positive results from all of the units and noted that there are bubbles on the bottom of the vail 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 fse was dispatched and found worn blower motor coupler.So replaced worn blower motor coupler.The instrument was deemed functional and handed over to the customer for use.This is a confirmed failure of the bd product.The root cause was determined to be a worn blower motor coupler.A corrective action and preventative action (capa#2660061) have been opened to determine root cause and implement corrective actions.Review of the device history record is not required due to the age of the instrument.Service history record review revealed one previous complaints for this issue (2204236).Bd quality did not receive any returned parts or instrument for investigation.The root cause was due to worn blower motor coupler.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.H3 other text : see h.10.

Event Description

It was reported while testing with bd bactec¿; fx, instrument top, packaged false positive results were obtained.There was no report if repeat or confirmatory testing was performed.There was no 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: 11388619
• MDR Text Key: 255354605
• Report Number: 1119779-2021-00402
• 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,Followup
• Report Date: 09/13/2021

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: 02/02/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 03/01/2021; 09/13/2021
• Supplement Dates FDA Received: 03/01/2021; 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1