MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT; SYSTEM, BLOOD CULTURING

Catalog Number	442153
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using the bd bactec¿ fos¿ (fastidious organism supplement) kit biological contamination was identified.There was no patient involvement or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bactec fos supplement kit batch 3249737 is composed of fos supplement batch 3214672 and fos reconstitution fluid batch 3214676.Batch history record review for bactec fos supplement kit batch 3249737 was satisfactory.No notifications were generated during manufacturing and no other complaints have been taken on this batch.Bactec fos supplement is manufactured by rehydrating components in usp purified water and mixed into a homogenous solution.The solution is then sterile filtered, dispensed into vials and stoppered by machine.The vials are lyophilized, and crimp caps are applied per standard operating procedures (sop).Bactec fos reconstitution fluid is manufactured by rehydrating the media components with usp purified water and mixed until a homogenous solution is obtained.The solution is dispensed into vials and capped and crimped per sop.Vials are autoclaved in an air over pressure (aop) autoclave; per manufacturing instructions, using a validated cycle.Post autoclaving, vials are labeled and packaged in a separate packing area.Four fos supplement vials are then manually packaged with one fos reconstitution fluid vial to make a bactec fos supplement kit (material 442153).Batch history record reviews for fos supplement batch 3214672 and fos reconstitution fluid batch 3214676 were satisfactory and no notifications were generated during manufacturing.Qc inspection and testing were satisfactory at time of release.No other complaints have been taken either batch.Retentions of batch 3214676 (reconstitution fluid) were not available; however, batch 3214672 (fos supplement) were available and used for further investigation.There were no observed defects in the available retentions.Two fos supplement vials were reconstituted with sterile water and incubated for 7 days.One was placed into 20-25 degree c incubation, and one was placed into 33-37 degree c incubation.There was no growth observed after incubation.There were no photos or returns submitted to assist with this investigation.This complaint cannot be confirmed.No complaint trends for this defect have been identified for this product; no actions are indicated at this time.Bd will continue to trend for defects.
Event or Problem Description
It was reported while using the bd bactec¿ fos¿ (fastidious organism supplement) kit biological contamination was identified.There was no patient involvement or consequences reported.

• Brand Name: BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT
• 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: 19115473
• Report Number: 1119779-2024-00293
• Device Sequence Number: 12538225
• Product Code: MDB
• UDI-Device Identifier: 30382904421534
• UDI-Public: (01)30382904421534
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K920933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 07/30/2024
• Device Catalogue Number: 442153
• Device Lot Number: 3249737
• 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: 03/22/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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