MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ OADC; SYSTEM, BLOOD CULTURING

Catalog Number	245116
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information for the additional 510k is as follows: g.4.Pma/510(k)#: k974883.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 before using bd bbl¿ mgit¿ oadc, one (1) carton box was received with no product label, batch number, or expiration date.There were no health impact or consequences reported.
Event or Problem Description
It was reported before using bd bbl¿ mgit¿ oadc, one (1) carton box was received with no product label, batch number, or expiration date.There were no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary - bactec mgit oadc enrichment (material 245116) is manufactured by mixing media components into a homogenous solution.The solution is then sterile filtered and dispensed into vials; stoppers are manually placed in the vial opening; septum caps are manually placed on top of the stopper and then mechanically crimped per standard operating procedure.Six bactec mgit oadc enrichment vials are then manually packaged into a carton to complete the kit.The batch history record review for batch 4200085 was satisfactory and no quality notifications were generated during manufacturing and inspection.The packaging process was within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples maintained for this product are of the component vials only and not the final shelf pack configuration.Retention sample inspection is not indicated for this complaint.Four photos were received for this investigation.All four photos show different views of a closed carton that is consistent for material 245116 without a label.The contents of the box are not visible in the photos.No labels or product information is visible in the photos to confirm the product or batch information.No returns samples were received for investigation.The labeling process for material 245116 includes label reconciliation where the total number of labels issued is reconciled with the total quantity of labels applied on cartons, used in the batch history record, rejected and unused.Any discrepancies must be within allowable limits specified in the labeling control procedure.The label reconciliation for batch 4200085 shows there was an excess of one label after manufacturing.While this number is within acceptable limits, it would support the incident of one carton without a label.However, batch verification is not provided in the photos and procedures throughout the manufacturing, packaging and handling processes require in-process inspections.Any non-conformances found during any inspection are reconciled per procedure and there are no allowances for shipment of materials without any labeling present on the carton.Damage to packaging cartons at receipt are not considered a product defect.Bd ships product in temperature-controlled trucks to distribution centers.The outside of the shipping cartons are subject to handling and storage conditions at distribution centers and at the customer site.This complaint cannot be confirmed.Bd will continue to trend complaints for packaging defects.

• Brand Name: BD BBL¿ MGIT¿ OADC
• Common Device Name: SYSTEM, BLOOD CULTURING
• 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: 21345605
• Report Number: 1119779-2025-00056
• Device Sequence Number: 7835561
• Product Code: MDB
• UDI-Device Identifier: 30382902451168
• UDI-Public: (01)30382902451168(11)240718(17)260122(10)4200085
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K954932
• 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): 04/23/2025

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: 01/22/2026
• Device Catalogue Number: 245116
• Device Lot Number: 4200085
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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