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

Catalog Number 442153

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Date 10/21/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bactec¿ fos¿ (fastidious organism supplement) kit, false negative result was obtained.No patient impact.The following information was provided by the initial reporter: false negative csf sample csf sample inoculated in bactec peds bottle with fos added was negative after 5 days of incubation, the same sample when inoculated directly on blood agar plate gave growth of klebsiella pneumoniae after 24 hours.All preparation procedures were respected.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.

Manufacturer Narrative

The following fields have been updated with additional/corrected information: d.4.Medical device lot #: 2362132.D.4.Medical device expiration date: 18-oct-2023.H.1.Device manufacture date: 28-dec-2022.H.6.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).Fos supplement batch number 2322551 was provided for investigation.Manufacturing records were reviewed, and fos supplement batch number 2322551 was only packaged into fos kit batch number 2362132.Shipping records were reviewed, and fos kit batch number 2362132 was distributed in europe.The batch history record for fos kit batch 2362132 was satisfactory and no quality notifications were generated during manufacturing.No other complaints have been taken on fos kit batch 2362132.The batch history record for fos supplement batch 2322551 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling and lyophilization process were within specifications.Qc inspection and testing were satisfactory at time of release.Retention samples from batch 2322551 (10 vials) were available for inspection.Retention samples were reconstituted with fos reconstitution fluid and supplemented into bactec culture media bottles as described in the ifu (instructions for use; available on bd.Com/e-labeling) for material 442153.The standard performance protocol for fos supplement includes growth testing of neisseria meningitidis atcc 13090 and haemophilus influenzae atcc 10211.Klebsiella pneumoniae is not tested as in the standard performance protocol, however, k.Pneumoniae atcc 33495 was available and tested like atcc 13090 and atcc 10211 for this investigation.Growth of atcc 13090 and atcc 10211 were satisfactory per procedures with fos supplement batch 2322551.Atcc 33495 had detectible growth in bactec culture media bottles with fos supplement and bottles without fos supplement (control).No return samples or photos were received for investigation.Retention sample testing did not find a defect of fos supplement batch 2322551.This complaint cannot be confirmed for a performance defect.Bd will continue to trend complaints for performance.

Event Description

It was reported that while using bd bactec¿ fos¿ (fastidious organism supplement) kit, false negative result was obtained.No patient impact.The following information was provided by the initial reporter: false negative csf sample csf sample inoculated in bactec peds bottle with fos added was negative after 5 days of incubation, the same sample when inoculated directly on blood agar plate gave growth of klebsiella pneumoniae after 24 hours all preparation procedures were respected.

• Brand Name: BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT
• Type of Device: 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: 18109962
• MDR Text Key: 327897109
• Report Number: 1119779-2023-01212
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382904421534
• UDI-Public: (01)30382904421534
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K920933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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
• Device Operator: Other
• Device Expiration Date: 10/18/2023
• Device Catalogue Number: 442153
• Device Lot Number: 2362132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1