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	05/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while testing with bd bactec¿ fx, instrument bottom, packaged false positive results were obtained.This occurred 10 times.Confirmatory testing was performed using gram staining.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: the specimens in question were all originally processed in other drawers of the instrument with the specimens being loaded into drawer c and having their protocol length changed to ten days.No instrument issue found.Issue resolved.S/n: (b)(4).Customer problem: (b)(6) called to report having multiple positives from drawer c of this fx instrument.(b)(6) indicated they had three specimens that flagged as positive at or near the same time that all showed no growth when confirmed with gram stain.(b)(6) indicated that they were different bottle types."vials affected (for blood culture only)?" y, ten.Drawer c multiple positives.
Event or Problem Description
It was reported while testing with bd bactec¿ fx, instrument bottom, packaged false positive results were obtained.This occurred 10 times.Confirmatory testing was performed using gram staining.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: the specimens in question were all originally processed in other drawers of the instrument with the specimens being loaded into drawer c and having their protocol length changed to ten days.No instrument issue found.Issue resolved.S/n: (b)(6) customer problem: s called to report having multiple positives from drawer c of this fx instrument.S indicated they had three specimens that flagged as positive at or near the same time that all showed no growth when confirmed with gram stain.S indicated that they were different bottle types.Vials affected (for blood culture only)? y, ten.Drawer c multiple positives.
Additional Manufacturer Narrative
H.6.Investigation summary: a complaint of "drawer c multiple positives" was received against instrument bottom bactec fx, material no: 441386, serial no: (b)(6).The complaint is not confirmed because no instrument issues were identified and the root cause is "unknown".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 (b)(6) 2013.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 may 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.

• 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: 14604689
• Report Number: 1119779-2022-00819
• Device Sequence Number: 4981409
• Product Code: MDB
• UDI-Device Identifier: 00382904413866
• UDI-Public: 00382904413866
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/12/2022

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: 05/09/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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