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

Catalog Number	245116
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd bbl¿ mgit¿ oadc enrichment, bottle contamination was present which led to a control sample growing microbacterium testaceum.There was no health impact or consequences reported.
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.G.5.Pma / 510(k)#: k954932, k974883 h.3.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 when using the bd bbl¿ mgit¿ oadc enrichment, bottle contamination was present which led to a control sample growing microbacterium testaceum.There was 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 was reviewed and was satisfactory per internal procedures.Formulation, filling, torquing, and packaging processes were within specifications.In process checks were performed at the designated intervals.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed and there are no other complaints on this batch.Retention samples from batch 2343383 were expired and not available for inspection.There were no photos submitted nor returns received to assist with the investigation of this complaint.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination.

• Brand Name: BD BBL¿ MGIT¿ OADC ENRICHMENT
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19303386
• Report Number: 1119779-2024-00376
• Device Sequence Number: 12600513
• Product Code: MDB
• UDI-Device Identifier: 30382902451168
• UDI-Public: (01)30382902451168
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: SEE H.10
• 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): 10/28/2024

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: 05/31/2024
• Device Catalogue Number: 245116
• Device Lot Number: 2343383
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2022
• 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