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	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown 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 the bd bactec¿ fos¿ culture supplement kit, the media was observed to be contaminated and cloudy.This event occurred with one (1) kit.There was no health impact or consequences reported.
Event or Problem Description
It was reported before using the bd bactec¿ fos¿ culture supplement kit, the media was observed to be contaminated and cloudy.This event occurred with one (1) kit.There was no health impact or consequences reported.
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).No batch number, returns or photos were provided for investigation.Retention samples cannot be evaluated without a specific batch number.The complaint history was reviewed for material 442153 and there are no trends in any batch over the last 12 months.Bd will continue to trend for this issue.This complaint cannot be confirmed.

• 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: 20453214
• Report Number: 1119779-2024-00752
• Device Sequence Number: 12540165
• Product Code: MDB
• UDI-Device Identifier: 30382904421534
• UDI-Public: (01)30382904421534
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/24/2024

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 Catalogue Number: 442153
• Device Lot Number: UNKNOWN
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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