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

Catalog Number	249560
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported after using one (1) bd bactec¿ subculturing/aerobic venting unit, a staff member punctured their thumb when their thumb slipped into the covering, while trying to dispose of the used venting needle.The needle was from a blood culture bottle that was positive for klebsiella pneumonia.There was no health impact or consequences reported.
Additional Manufacturer Narrative
The following field has been updated with corrected information: h1: type of reportable events - changed from "serious injury" to "malfunction".
Event or Problem Description
It was reported after using one (1) bd bactec¿ subculturing/aerobic venting unit, a staff member punctured their thumb when their thumb slipped into the covering, while trying to dispose of the used venting needle.The needle was from a blood culture bottle that was positive for klebsiella pneumonia.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: this memo serves to summarize the findings on your recent complaint on product 249560 (vent aerobic), lot number 5044954, where a needle stick injury from positive blood culture occurred.Event description: "the customer reported that a staff member was disposing a used venting needle, their thumb slipped into the covering over the sharp female connector of the needle" complaint history review: a review of past complaints for this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of the device history record does not indicate any manufacturing issues.Sample analysis: no photos or returns were provided.10 retention samples were visually inspected with no issues being identified.Evaluations results: based on the investigation, no defect was observed, and the retention samples were satisfactory.No complaint trend exists.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.As no complaint trends are present at this time, no further action will be taken.Bd will continue to monitor trending.
Event or Problem Description
It was reported after using one (1) bd bactec¿ subculturing/aerobic venting unit, a staff member punctured their thumb when their thumb slipped into the covering, while trying to dispose of the used venting needle.The needle was from a blood culture bottle that was positive for klebsiella pneumonia.There was no health impact or consequences 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: 22883105
• Report Number: 1119779-2025-04286
• Device Sequence Number: 18551934
• Product Code: JTA
• UDI-Device Identifier: 00382902495604
• UDI-Public: (01)00382902495604(11)250321(17)270131(10)5044954
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 10/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 249560
• Device Lot Number: 5044954
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 10/03/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 08/26/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown