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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/19/2022

Event Type  malfunction  

Event Description

It was reported that while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) there was possible contamination.The customer has seen a sudden increase in the number of isolates of paenibacillus in patients with low suspicion of sepsis.The customer is unaware of any reporting errors or patient effects.The following information was provided by the initial reporter: possible contamination.Customer has seen a sudden increase in the number of isolates of paenibacillus in patients with low suspicion of sepsis.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been corrected with the following information: multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2041396.D.4.Medical device expiration date: 2022-12-31.H.4.Device manufacture date: 2022-02-10.D.4.Medical device lot #: 2094376.D.4.Medical device expiration date: 2023-01-31.H.4.Device manufacture date: 2022-04-04.D.4.Medical device lot #: 2102631.D.4.Medical device expiration date: 2023-01-31.H.4.Device manufacture date: 2022-04-12.

Event Description

It was reported that while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) there was possible contamination.The customer has seen a sudden increase in the number of isolates of paenibacillus in patients with low suspicion of sepsis.The customer is unaware of any reporting errors or patient effects.The following information was provided by the initial reporter: possible contamination.Customer has seen a sudden increase in the number of isolates of paenibacillus in patients with low suspicion of sepsis.

Manufacturer Narrative

H.6 investigation summary: catalog 442021.Batch no.2041396, 2094376 & 2102631.Customer reported a paenibacillus contamination issue while using bactec product.Neither photos nor returned good samples were received.A graph of quantity of occurrence was received.Bd was unable to reproduce the customer¿s experience with bactec product.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 numbers and the ¿as reported¿ defect code.Complaint is unconfirmed based on retention samples and batch history record review results.Nonetheless a corrective and preventive action initiation determination (cid) was performed to evaluate the necessity of a capa due to this defect.No capa action was required.Several evaluations were performed to conclude that the bio-contaminant paenibacillus did not originated from bd manufacturing site.The autoclave process was evaluated.The moist heat autoclave is a process that uses moist heat as the lethal agent to render liquid and porous/hard goods items free from viable microorganism and relies on direct contact with saturated steam, which is water vapor in equilibrium with liquid water.The autoclave process is accomplished by the heat transfer from the steam to the load and by hydrating effect of the resultant condensate that forms due to the change in state from vapor to the lower energy liquid state.This phase change requires the transfer of the latent heat of the steam to the surroundings, thus heating the autoclave and its load.Bd cayey autoclave the products via moist heat.Initial validation had been successfully completed and the required re-qualification assessment has been performed accordingly maintaining the active and valid autoclaving cycle.Environmental samples were evaluated from bd manufacturing site for identification of bacterial species present at different locations within the manufacturing plant.The purpose of identifying these isolates was to determine if paenibacillus contamination originated from this location.After performing maldi testing none of the environmental samples collected from different locations within the manufacturing plant in bd cayey were identified as paenibacillus.Therefore, the bio-contaminant paenibacillus likely did not originate from the bd cayey, and there is no evidence to indicate that it would it have survived the autoclaving process of bactec bottles.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.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.

Event Description

It was reported that while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) there was possible contamination.The customer has seen a sudden increase in the number of isolates of paenibacillus in patients with low suspicion of sepsis.The customer is unaware of any reporting errors or patient effects.The following information was provided by the initial reporter: possible contamination.Customer has seen a sudden increase in the number of isolates of paenibacillus in patients with low suspicion of sepsis.

• 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: 15506278
• MDR Text Key: 306262461
• Report Number: 2647876-2022-00197
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• 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: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• 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