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

Catalog Number	249560
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after using one bd bactec¿ subculturing/aerobic venting unit, blood was exposed to the ceiling of the safety cabinet when the venting unit was inserted in the safety cabinet.User wore ppe and no health impact or consequence reported.
Additional Manufacturer Narrative
E1: initial reporter facility name:(b)(6).This site is an oem manufacturing site.Therefore, bd corporate headquarters in sparks, md has been listed in sections d.3.And g.1.And the sparks fda registration number has been used for the manufacture report number.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: this memo summarizes the findings on your recent complaint 13330474 on product 249560 (vent aerobic 50 ea).The batch number was not provided.Customer reported lytic bottle blood exposure when using venting unit.After the lytic bottle was positive, the venting unit was inserted in the safety cabinet and blood was exposed to the ceiling of the safety cabinet.The cap was removed first and then set on the bottle.A review of past complaints over the past 12 months for the reported product does not indicate a trend for this issue.A bhr (batch history record) review could not be completed since the batch number was not provided.The testing of retain samples could not be completed since the batch number was not provided.No pictures or samples were provided for evaluation.Based on the investigation, the complaint was not confirmed, and no definitive root cause could be established for the reported defect.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 after using one bd bactec¿ subculturing/aerobic venting unit, blood was exposed to the ceiling of the safety cabinet when the venting unit was inserted in the safety cabinet.User wore ppe and 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. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23543593
• Report Number: 1119779-2025-05437
• Device Sequence Number: 9609954
• Product Code: JTA
• UDI-Device Identifier: 30382902495605
• UDI-Public: (01)30382902495605
• 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): 02/19/2026

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: Other
• Device Catalogue Number: 249560
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/23/2026
• 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