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

Catalog Number	249560
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter address: (b)(6).The manufacturing location for this product is bd acquisition in broken bow, nebraska.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.
Event or Problem Description
It was reported while using bd bactec¿ subculturing/aerobic venting unit that one (1) needle separated from the device holder.The needle was unable to be removed from the septum of the positive blood culture bottle.There was no health impact or consequence reported.
Event or Problem Description
It was reported while using bd bactec¿ subculturing/aerobic venting unit that one (1) needle separated from the device holder.The needle was unable to be removed from the septum of the positive blood culture bottle.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: bd received two photos for investigation.The first photo shows the vented needle stuck inside the septum of the blood culture bottle.It was missing the plastic holder, which would be used to safely remove the needle from the bottle.The second photo shows the product package for material and batch verification.Retention samples were evaluated by visual examination and no issues were observed as all specifications were met.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 21328118
• Report Number: 1119779-2025-00042
• Device Sequence Number: 7865860
• Product Code: JTA
• UDI-Device Identifier: 30382902495605
• UDI-Public: (01)30382902495605(11)230703(17)250619(10)3142356
• 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
• Report Date (Section B): 03/06/2025

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 Expiration Date: 06/19/2025
• Device Catalogue Number: 249560
• Device Lot Number: 3142356
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2023
• 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