MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Catalog Number	442027
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 that while using bd bactec¿ standard/10 aerobic/f culture vials (plastic), there were false negative results of three samples.No patient impact reported.The following information was provided by the initial reporter: "false negative result.The negative sample was sent to a support laboratory, which found positivity in the slide and growth in the plate.".
Event or Problem Description
It was reported that while using bd bactec¿ standard/10 aerobic/f culture vials (plastic), there were false negative results of three samples.No patient impact reported.The following information was provided by the initial reporter: "false negative result.The negative sample was sent to a support laboratory, which found positivity in the slide and growth in the plate.".
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2647876-2023-00104 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.

• Brand Name: BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC)
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17604223
• Report Number: 2647876-2023-00104
• Device Sequence Number: 6139596
• Product Code: MDB
• UDI-Device Identifier: 00382904420277
• UDI-Public: 00382904420277
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K161810
• 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): 10/09/2023

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 442027
• Device Lot Number: 2333795
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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