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

Model 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	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using 4 bd bactec¿ fos¿ (fastidious organism supplement) kit contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " noticeable cloudiness on 4 tubes, discarded and not used".
Event or Problem Description
It was reported that while using 4 bd bactec¿ fos¿ (fastidious organism supplement) kit contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "noticeable cloudiness on 4 tubes, discarded and not used".
Additional Manufacturer Narrative
Investigation summary: bactec fos supplement kit (442153) batch 1082476 is composed of fos supplement batch 1021760 and fos reconstitution fluid batch 1014941.Batch history record review for bactec fos supplement kit batch 1082476 was satisfactory.No quality notifications were generated during manufacturing.The complaint history was reviewed, and no other complaint have been taken on this kit batch for performance.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.Tubes 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).Retention samples maintained for this product include the individual components but not the kitted configuration, so retention sample inspection is not indicated for this complaint.However, retention samples of fos supplement batch 1021760 (10 vials) were available for inspection.No crimp, vial or media defects were observed in 10/10 retention vials.Likewise, retention samples of fos reconstitution fluid batch 1014941 (8/8 vials) had no observable defects from visual inspection.As a courtesy to the customer, the retentions were tested.One retention fos reconstitution fluid batch 1014941 was used to reconstitute one retention bactec fos supplement vial from batch 1021760.The fluid appeared as the package insert instructed for retention sample, the supplement vials had a turbid appearance.The vials were then placed into the 33-37 degree c incubator for 7 days.At the end of the 7 days no microbial growth was seen the retention vial.The fluid was further test for growth by plating the fluid on tsa sheep blood agar.Neither the incubated fluid nor the plated fluid showed signs of microbial growth.The package insert for this product does indicate that media containing fos will appear slightly turbid.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This compliant cannot be confirmed.Bd will continue to trend complaints for appearance.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12229324
• Report Number: 1119779-2021-01220
• Device Sequence Number: 3357414
• Product Code: MDB
• UDI-Device Identifier: 30382904421534
• UDI-Public: 30382904421534
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/04/2022

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: 01/13/2022
• Device Model Number: 442153
• Device Catalogue Number: 442153
• Device Lot Number: 1082476
• 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: 06/28/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• 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