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

Catalog Number	442023
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	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.E.1.Initial reporter facility name: (b)(6).H4.Device manufacture date: unknown.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.Pma / 510(k)#: k222591.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 using bd bactec¿ plus aerobic/f culture vials (plastic) there was no growth of helicobacter cinaedi seen in one bottle.No adverse impact was reported regarding the patient or user at this time.
Event or Problem Description
It was reported while using bd bactec¿ plus aerobic/f culture vials (plastic) there was no growth of helicobacter cinaedi seen in one bottle.No adverse impact was reported regarding the patient or user at this time.
Additional Manufacturer Narrative
Investigation summary: catalog: 442023 batch no.Unknown customer reported no growth while using bactec product.Neither photos nor returned good samples were received.Bd was not able to perform an investigation to the retention samples since batch number is unknown.A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Complaint is unconfirmed.No correctives actions were required.Quality control certificates list test organism, including atcc¿ culture specified in the clsi standard m22, quality control for commercially prepared microbiological culture media for expected atcc performance.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.

• Brand Name: BD BACTEC¿ PLUS 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23485007
• Report Number: 2647876-2025-00660
• Device Sequence Number: 18698968
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: (01)00382904420239
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: 442023
• Device Lot Number: UNKNOWN
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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