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

Catalog Number 441385

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  malfunction  

Event Description

It was reported that while using bd bactec¿ fx, instrument top, packaged samples were found to be false negative.This is a report of a single occurrence.No false results were reported out to the clinician or patient.The following information was provided by the initial reporter: there was an anaerobic bottle with a protocol length of 5 days which was still in the bactec.At 6.6 days, the bottle flagged as positive.The customer asks why this occurred when no extended protocol length was requested.

Manufacturer Narrative

Medical device expiration date: medical na.Initial reporter phone #: (b)(6).Initial reported fax #: (b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: bd support explained that the instrument will continue to incubate and monitor for signs of growth even after the protocol.Bottles that are left in past protocol have a potential to flag positive for a number of reasons including contamination, slow growing organisms, blood cell metabolic growth, or other factors which is why protocol time specifications are given.Based on this information, the instrument is functioning as intended and this complaint is unconfirmed as no problem found.Device history record review is not required as this does not allege an early life failure or failure at install.Service history review showed no prior complaints reported for false positives.Sample analysis is not required as no samples were returned for investigation.The root cause is undetermined as there is no problem found with the instrument.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.Complaints for results are under statistical control for the month of july 2022.The upper control limit was not breached, and no trends have been identified.Review of risk management documentation indicates the potential risk of the reported failure mode was assessed as severity s1 for all false positives not resulting in pathogen exposure or patient misassociation via document baltrmbactecinstraph rev 15, row 1.0a-1.10g.

Event Description

It was reported that while using bd bactec¿ fx, instrument top, packaged samples were found to be false negative.This is a report of a single occurrence.No false results were reported out to the clinician or patient.The following information was provided by the initial reporter: there was an anaerobic bottle with a protocol length of 5 days which was still in the bactec.At 6.6 days, the bottle flagged as positive.The customer asks why this occurred when no extended protocol length was requested.

• 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
• 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: 15161321
• MDR Text Key: 304959902
• Report Number: 1119779-2022-01058
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: 382904413859
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K915796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 441385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1