MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC MGIT 320 INSTRUMENT; SYSTEM, BLOOD CULTURING

Catalog Number	441743
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
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
Report 1 of 2.It was reported that while using bd bactec mgit 320 instrument, there was false resistance seen in the results of one (1) sample.The result was shown as complete and with resistance to some drugs, but the sample trace did not show any curve growth in any of the tubes analyzed.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary catalog # 441743, s/n (b)(6): the customer reported since the first training session, after the equipment was installed, the tsas have been released with the same incorrect interpretation as shown in the attached figure.Epicenter shows the result as complete and with resistance to some drugs, but the sample trace does not show any curve growth in any of the tubes analyzed.Through bd technical support a review of three samples was performed.No instrument errors were reported, however, it was reported that the epicenter had lost connection to the instrument and did not detect the last reading from the instrument.The customer was instructed to repeat the testing and the case, (b)(4), was closed.The root cause of the reported issue was not determined.This complaint is not being confirmed as no instrument malfunction was identified.Review of the device history record for instrument s/n (b)(6) is not required because this complaint does not allege an early life failure or failure at installation and the instrument has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed for the instrument and no recent additional work orders were observed for the complaint failure mode reported.No samples or parts were expected to be returned for this complaint and thus, a returned sample analysis is not required.Bd quality will continue to closely monitor for trends associated with results related complaints.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.
Event or Problem Description
Report 1 of 2 it was reported that while using bd bactec mgit 320 instrument, there was false resistance seen in the results of one (1) sample.The result was shown as complete and with resistance to some drugs, but the sample trace did not show any curve growth in any of the tubes analyzed.No adverse impact was reported regarding the patient or user.

• Brand Name: BD BACTEC MGIT 320 INSTRUMENT
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20734919
• Report Number: 1119779-2024-00907
• Device Sequence Number: 8614236
• Product Code: MDB
• UDI-Device Identifier: 00382904417437
• UDI-Public: (01)00382904417437(11)170112
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K974883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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 Catalogue Number: 441743
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2017
• 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