MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ SUBCULTURING/AEROBIC VENTING UNIT; MONITOR, MICROBIAL GROWTH

Catalog Number	249560
Medical Device Problem Codes	Product Quality Problem (1506); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd bactec¿ subculturing/aerobic venting unit, the venting unit needle and adapter were disconnected during use.There was no health impact or consequence reported.
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.
Additional Manufacturer Narrative
Investigation summary: this memo summarizes the findings on your recent complaint 14019376 on product 249560 (vent aerobic 50 ea), batch number 5155191.It was reported that the venting unit needle and adapter were disconnected during use.Historical complaint data for sku 249560 shows no trend for the reported issue over the past year.A review of the batch history record (bhr) for the reported batch confirms that all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing or release of the product.Retain samples have been retrieved for visual inspection, all samples were found compliant.No physical samples were returned for analysis, however the 1 image provided confirm the validity of the complaint.Based on the investigation no definitive root cause could be determined.As no complaint trends are present at this time, no further action will be taken.Bd will continue to monitor trending for this issue.
Event or Problem Description
It was reported that while using bd bactec¿ subculturing/aerobic venting unit, the venting unit needle and adapter were disconnected during use.There was no health impact or consequence reported.

• Brand Name: BD BACTEC¿ SUBCULTURING/AEROBIC VENTING UNIT
• Common Device Name: MONITOR, MICROBIAL GROWTH
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 24210478
• Report Number: 1119779-2026-00030
• Device Sequence Number: 9654228
• Product Code: JTA
• UDI-Device Identifier: 30382902495605
• UDI-Public: (01)30382902495605(11)250717(17)270531(10)5155191
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• 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): 04/10/2026

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: Health Professional
• Device Catalogue Number: 249560
• Device Lot Number: 5155191
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2025
• 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