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 10/13/2022

Event Type  malfunction  

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 Description

It was reported that bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) has contaminated bottles due to the isolation of paenibacillus urinalis group.The customer performed gram stain and organism id using bruker maldi.Customer is seeing about one a day with about 60% staining as gram negative rods and these are the isolates that might cause a patient to be put on unnecessary antibiotics.No patient impact has been reported.The following information was provided by the initial reporter: customer alleges contaminated bottles due to isolation of paenibacillus urinalis group from several bottles.Customer performed gram stain and organism id using bruker maldi, but we are seeing about one a day now with about 60% staining as gram negative rods and these are the isolates that might cause a patient to be put on unnecessary antibiotics.

Manufacturer Narrative

H.6 investigation summary: catalog 442021.Batch no.2094376.Customer reported a paenibacillus contamination issue while using bactec product.Neither photos nor returned good samples were 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 batch has been previously investigated for the reported defect.Blood background was performed with satisfactory results.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 reported, paenibacillus, did not originated from the 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 requalification assessment has been performed accordingly maintaining the active and valid autoclaving cycle.Isolates containing the biocontamination were received from the customer.Environmental samples were evaluated from bd manufacturing site for identification of bacterial species present at different locations within the plant.The purpose of identifying these isolates was to determine if paenibacillus contamination originated from this location.After performing maldi testing, the contaminants were identified as paenibacillus species in the samples from the customer, and none of the environmental samples collected from different locations within the manufacturing plant in bd cayey were identified as paenibacillus.Finally, autoclave testing of paenibacillus species present in all samples from the customer indicated that a 15-minute autoclave cycle at 118°c is sufficient to kill vegetative cells.Bd cayey cycle is set for a higher temperature that exceeds 15 minutes.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 bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) has contaminated bottles due to the isolation of paenibacillus urinalis group.The customer performed gram stain and organism id using bruker maldi.Customer is seeing about one a day with about 60% staining as gram negative rods and these are the isolates that might cause a patient to be put on unnecessary antibiotics.No patient impact has been reported.The following information was provided by the initial reporter: customer alleges contaminated bottles due to isolation of paenibacillus urinalis group from several bottles.Customer performed gram stain and organism id using bruker maldi.But we are seeing about one a day now with about 60% staining as gram negative rods and these are the isolates that might cause a patient to be put on unnecessary antibiotics.

• 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: 15636623
• MDR Text Key: 306783464
• Report Number: 2647876-2022-00221
• 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
• Report Date: 02/15/2023

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: 01/31/2023
• Device Model Number: 442021
• Device Catalogue Number: 442021
• Device Lot Number: 2094376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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