MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Model Number 442021

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  Injury  

Event Description

It was reported by the customer that they had a possible contamination with bd bactec¿ lytic/10 anaerobic/f culture vials (plastic), where the bottles have gone positive on the instrument and the microorganism detected was bacillus cereus.There was 3 different occurrences in this event.Effecting 3 different patients.The following information was provided by the customer: " customer reports a possible contamination on media ref#: 442021, lot#: 2041407, with bacillus cereus.Customer is using instrument ft7592.Customer reports 3 different patients were the bottles have gone positive on the instrument and the microorganism detected was bacillus cereus.(this was on media (b)(4)).

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Correction: b1: adverse type: reported issue is both adverse event and product problem.B2: event attributed to: required intervention.B5: describe event or problem: updated.D1: type of reportable events: serious injury.

Event Description

It was reported by the customer that they had a possible contamination with bd bactec¿ lytic/10 anaerobic/f culture vials (plastic), where the bottles have gone positive on the instrument and the microorganism detected was bacillus cereus.There was 3 different occurrences in this event.Effecting 3 different patients.The following information was provided by the customer: "customer reports a possible contamination on media ref#: 442021 lot#: 2041407 with bacillus cereus.Customer is using instrument ft7592.Customer reports 3 different patients were the bottles have gone positive on the instrument and the microorganism detected was bacillus cereus.(this was on media 442021 and 442023)patients were treated for bacillus cereus.

Event Description

It was reported by the customer that they had a possible contamination with bd bactec¿ lytic/10 anaerobic/f culture vials (plastic), where the bottles have gone positive on the instrument and the microorganism detected was bacillus cereus.There was 3 different occurrences in this event.Effecting 3 different patients.The following information was provided by the customer: " customer reports a possible contamination on media ref#: 442021 lot#: 2041407 with bacillus cereus.Customer is using instrument ft7592.Customer reports 3 different patients were the bottles have gone positive on the instrument and the microorganism detected was bacillus cereus.(this was on media 442021 and 442023) patients were treated for bacillus cereus.

Manufacturer Narrative

H.6 investigation summary: retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Complaint is unconfirmed based on retention samples and batch history record review results.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.No corrective actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.

• Brand Name: BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15306324
• MDR Text Key: 305352779
• Report Number: 2647876-2022-00188
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420215
• UDI-Public: 00382904420215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Model Number: 442021
• Device Catalogue Number: 442021
• Device Lot Number: 2041407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention