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

Catalog Number	442153
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	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd bactec¿ fos¿ culture supplement kit, bacillus contamination growth was observed in the media involving two (2) different kit batches when processing quality control.There were no health impact or consequences reported as patient samples were not affected.
Additional Manufacturer Narrative
The information for the additional medical device lot # is as follows: d4.Medical device lot #: 4141974.D4.Medical device expiration date: 25-mar-2025.H4.Device manufacture date: 20-may-2024.D4.Unique identifier (udi) #: (b)(4).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 bactec¿ fos¿ culture supplement kit, bacillus contamination growth was observed in the media involving two (2) different kit batches when processing quality control.There were no health impact or consequences reported as patient samples were not affected.
Additional Manufacturer Narrative
Investigation summary - 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).For 442153/4141974: bactec fos supplement kit batch 4141974 is composed of fos supplement batch 4088690 and fos reconstitution fluid batch 4103110.Batch history record review for bactec fos supplement kit batch 4141974 was satisfactory.No notifications were generated during manufacturing and no other complaints have been taken on this batch.Batch history record reviews for fos supplement batch 4088690 and fos reconstitution fluid batch 4103110 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.There were no photos or returns submitted to assist with this investigation.Retentions of batch 4103110 (reconstitution fluid) and retentions of batch 4088690 (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 two reconstitution fluid vials and incubated for 14 days.One was placed into 20-25 degree c incubation, and one was placed into 33-37 degree c incubation.No growth was observed in the samples after incubation.This complaint for bactec fos supplement kit batch 4141974 cannot be confirmed for contamination.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 contamination defects.For 442153/4059819: bactec fos supplement kit batch 4059819 is composed of fos supplement batch 4040250 and fos reconstitution fluid batch 4011793.Batch history record review for bactec fos supplement kit batch 4059819 was satisfactory.No notifications were generated during manufacturing and no other complaints have been taken on this batch.Batch history record reviews for fos supplement batch 4040250 and fos reconstitution fluid batch 4011793 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.There were no photos or returns submitted to assist with this investigation.Retentions of batch 4011793 (reconstitution fluid) and retentions of batch 4040250 (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 two reconstitution fluid vials and incubated for 14 days.One was placed into 20-25 degree c incubation, and one was placed into 33-37 degree c incubation.No growth was observed in the samples after incubation.This complaint for bactec fos supplement kit batch 4059819 cannot be confirmed for contamination.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 contamination defects.
Additional Manufacturer Narrative
The following updates have been made: this mdr pertains only to lot number 4059819.B5.It was reported while using bd bactec¿ fos¿ culture supplement kit, the customer found contamination in an unknown quantity of media during quality control testing.There was no report of patient impact.This record is being reopened to address the corrections required for capa pr 11910483.
Event or Problem Description
It was reported while using bd bactec¿ fos¿ culture supplement kit, the customer found contamination in an unknown quantity of media during quality control testing.There was no report of patient impact.

• Brand Name: BD BACTEC¿ FOS¿ CULTURE 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21332653
• Report Number: 1119779-2025-00044
• Device Sequence Number: 8604018
• Product Code: MDB
• UDI-Device Identifier: 30382904421534
• UDI-Public: (01)30382904421534(11)240228(17)250108(10)4059819
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2025

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: 01/08/2025
• Device Catalogue Number: 442153
• Device Lot Number: 4059819
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 05/05/2025; 09/22/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 05/07/2025; 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• 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