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

Model Number 442021

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 09/19/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) from (b)(6) 2019 - (b)(6) 2022 the customer had 92 occurrences of potential contamination.Two patients were treated based on results.The vials flagged positive on the bactec instrument and the maldi analyzer was used for identification.Paenibacillus urinalis was isolated.Patient was treated with antibiotics.1 of 2 patients impacted.The following information was provided by the initial reporter.The customer stated: "customer alleges contaminated bottles due to isolation of paenibacillus urinalis group from several bottles" "patient treatment was impacted as patients were administered antibiotics unnecessarily".

Manufacturer Narrative

H.6 investigation sumamry: catalog 442023, batch no.(b)(6).Customer reported a paenibacillus contamination issue while using bactec product.One excel spreadsheet 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.Blood background was performed with satisfactory results.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.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.Catalog 442023, batch no.Unknown.Customer reported a paenibacillus contamination issue while using bactec product.One excel spreadsheet was received.Bd was not able to perform an investigation to the retention samples since batch number is unknown.A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Complaint is unconfirmed.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.H3 other text : see h.10.

Event Description

It was reported while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) from (b)(6) 2019 ,(b)(6) 2022 the customer had 92 occurrences of potential contamination.Two patients were treated based on results.The vials flagged positive on the bactec instrument and the maldi analyzer was used for identification.Paenibacillus urinalis was isolated.Patient was treated with antibiotics.1 of 2 patients impacted.The following information was provided by the initial reporter.The customer stated: "customer alleges contaminated bottles due to isolation of paenibacillus urinalis group from several bottles"."patient treatment was impacted as patients were administered antibiotics unnecessarily".

• 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: 15577222
• MDR Text Key: 301511723
• Report Number: 2647876-2022-00210
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420215
• UDI-Public: (01)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

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 442021
• Device Catalogue Number: 442021
• Device Lot Number: UNKNOWN
• 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
• 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