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

Model Number	441386
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bactec¿ fx, instrument bottom, packaged, false positive results were acquired on patient samples.The following information was provided by the initial reporter: "fx441386 / drawer c rows j/k unusable.Customer had this issue with drawer c rows j/k going unusable.They moved the vials in these rows right away, but shortly after they moved the vials 4 turned positive shortly after.3 aerob bottles and 1 anaerob.Customer did a gram stain and found no growth.They reinserted the vials to complete the protocol.These false positive results were not reported out.".
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: a complaint of "drawer c rows j/k unusable/ false positives" was received against instrument bottom bactec fx, material no: 441386, serial no: (b)(6).Field service engineer was dispatched and rack was replaced to resolve the issue.The complaint is confirmed.The root cause of false positives is not known.Review of device history record for instrument serial number, (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Device was installed on 5/27/2015.Samples were not received by quality for investigation and thus, returned material investigation could not occur.Service history review revealed no previous complaints for this issue.Complaints for ¿results¿ issues which included " false positives " complaints are under statistical control for the month of april 2022.The upper control limit was not breached.Quality will continue to monitor the " false positives ¿complaints.No trends were identified.Per baltrmbactecinstraph revision 15, the error related to this complaint is considered user inconvenience, which is an s1; reference row id 1.2c.No new risks or hazards were identified.
Event or Problem Description
It was reported that while using bd bactec¿ fx, instrument bottom, packaged, false positive results were acquired on patient samples.The following information was provided by the initial reporter: fx441386 / drawer c rows j/k unusable.Customer had this issue with drawer c rows j/k going unusable.They moved the vials in these rows right away, but shortly after they moved the vials 4 turned positive shortly after.3 aerobic bottles and 1 anaerobic.Customer did a gram stain and found no growth.They reinserted the vials to complete the protocol.These false positive results were not reported out.

• Brand Name: BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14272876
• Report Number: 1119779-2022-00642
• Device Sequence Number: 4355203
• Product Code: MDB
• UDI-Device Identifier: 00382904413866
• UDI-Public: 00382904413866
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K915796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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
• Operator of Device: Other
• Device Model Number: 441386
• Device Catalogue Number: 441386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown