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A customer in canada notified biomérieux of a cracked inoculated bact/alert® sn culture bottle (ref.(b)(4), lot (b)(6)) inside their bact/alert® 3d instrument.Complaint investigation (b)(4) was initiated in response to a clinical customer complaint (contact date (b)(6) 2021) from (b)(6) hospital, canada ((b)(6)).The customer reported when unloading a positive bottle (bact/alert sn lot (b)(6) (p/n 259790, expiry 04nov2021) from the bact/alert 3d instrument, they found a bottle that was broken.Blood from the bottle leaked in the cell and covered most of the identification of the bottle.The customer relocated all the remaining bottles in the drawer and decontaminated the area using the appropriate laboratory procedures.The broken bottle was discarded by the customer.The scope of the investigation is for bact/alert sn culture bottles from lot (b)(6) that exhibited bottle leakage during incubation in the bact/alert instrument.Impact: the customer reported a broken bottle with a crack on the bottom of a bottle from bact/alert sn lot (b)(6) (p/n 259790, expiry 04nov2021).A crack in the bottom of the bottle has the potential to expand when exposed to heat and the blood seeps out under the sensor, potentially interfering with reflectance readings from the cell.The customer confirmed that they received the inoculated blood culture bottle from another hospital and did not know how the bottle was transported or if the staff collecting the samples inspected the bottle prior to inoculation.Typically, a cracked bottom of a bact/alert bottle has a visible star-like pattern appearance due to a point of impact with a hard surface.Impact can be from the bottle being dropped or subjected to excessive mechanical compression impact or force.No impact/harm to patients since the customer draws the patient samples as a set of two culture bottles and only one of the bottles had a cracked bottom.The impact to the customer is the removal of the broken bottle from the instrument and the cleanup of the area as per their biohazard procedures.The impact to the business is that the customer¿s uncertainty of how the bottle cracked will cause customers to lose confidence in the system; however, this particular bottle issue is likely due to the bottle encountering an impact during the drawing process and/or transportation of the bottle to the laboratory.Immediate action by local customer service (lcs) and/or workaround e.G.Fse/work order (if applicable): through global customer service (gcs) support, lcs obtained information from the customer pertaining to bact/alert sn culture bottles that exhibited the presence of a crack on the bottom of the bottle.Gcs communicated to lcs that the bact/alert bottles are intended to be shatterproof; however, like most medical devices, they are susceptible to damage if dropped or handled with excessive mechanical compression impact.Gcs informed lcs that biomérieux recommends handling the culture bottles after they are unpacked and received at the customer site in a manner that prevents physical damage, documenting drops or other excessive impacts if they occur, and verifying the bottle is not damaged prior to loading into the instrument.Retain product testing: (b)(4) bottles from sn lot (b)(6) were inspected for any evidence of cracks on the bottom of the bottle.No broken, cracked, or leakage bottles were found during this inspection.Investigation: root cause analysis and conclusion: based on the evaluation of data, using the ishikawa method, three root causes were identified for the presence of a crack on the bottom of the bact/alert sn culture bottle pertaining to complaint (b)(4): measurement: a graph of the broken bottle was provided by the customer and attached to the complaint case ((b)(4)).The bottle flagged positive after 1.26 days of incubation.The graph associated with the bottle has dips in appearance during the beginning readings which is an indication of noise (disturbance).Noise can be evident with bottles that have encountered an impact sometime prior to loading into the instrument.Manpower: the customer reported a broken bottle with bact/alert sn lot (b)(6) (p/n 259790, expiry 04nov2021).In the cracked bottle, the blood passed under the sensor and into the cell of the bact/alert 3d instrument during incubation.The leakage also covered most of the identification of the bottle.The customer relocated all the remaining bottles in the draw and decontaminated the area using the appropriate laboratory procedures.The broken bottle was discarded by the customer.Blood collection for this sn culture bottle occurred at another hospital site and was transported to the customer¿s laboratory for testing.The customer could not confirm if the sn culture bottle was dropped during the inoculation or transport processes.The laboratory receives more than 100 culture bottles a day for testing.The customer did confirm that the sn culture bottle was not dropped by any laboratory personnel.The bact/alert user manual also cautions the user to inspect bottles prior to loading and if the bottle is cracked, do not load the bottle into the instrument.The customer did inform lcs that their protocol requires them to inspect the bottom of the culture bottles prior to loading the bottles into the instrument; however, the customer did not know the loading details around this particular sn culture bottle with a cracked bottom.The broken bottle was loaded into the bact/alert 3d instrument and the incubation heat triggered leakage of the bottle contents.As per cumitech 1c4, ¿blood culture bottles should be carried in some sort of container that will protect them from dropping and from knocking against each other.¿ customers are responsible for protecting the integrity of container and/or carrier devices that transport patient samples for clinical testing.This would include adding adequate padding around samples (e.G.Blood culture bottles) as the samples travel to required destinations (e.G.Laboratory testing services).Type of travel could include pneumatic tube systems, vehicles, and/or specimen carts.Transportation processes of blood culture bottles should be evaluated by the customer for the risks and tolerances of potential breakage of bottles within their own system(s).The bact/alert culture bottle is shatter resistant whereas if it encounters an impact (e.G.Dropped) it has the potential to crack but not into lots of small pieces.Any crack in the layers will compromise the structural integrity of the bottle.Any crack in zone 5 (the bottom of the bottle) will disrupt the function of the optical region where the detection of instrument readings that correspond to microbial growth occurs.According to the customer there was a 2-8 hour delay of reporting the patient results due to the fact that the organism isolated from the broken anaerobic sn bottle did not match the isolate obtained from the aerobic sa bottles (the mate bottle).The sn bottle was found to be broken when it flagged positive at 1.26 days and was unloaded from the bact/alert 3d instrument.The gram stain and subculture were performed on the positive bottle.There was no delay in the processing of a positive bottle; however, the laboratory decided to delay what to report to the physician due to the differences in the organisms found in each culture bottle type.In summary, completion of manufacturing activities were appropriately documented that met good manufacturing practices.The customer could not confirm if the sn culture bottle was dropped during the inoculation or transport processes.The customer requires inspection of the bottom of the culture bottles prior to loading the bottles into the instrument as per their internal procedures; however, the customer did not know the loading details around this particular sn culture bottle with a cracked bottom.The broken bottle was loaded into the bact/alert 3d instrument and the incubation heat triggered leakage of the bottle contents.Customers are responsible for protecting the integrity of container and/or carrier devices that transport patient samples for clinical testing.Transportation processes of blood culture bottles should be evaluated by the customer for the risks and tolerances of potential breakage of bottles within their own site.Machine: the customer receives more than 100 bact/alert culture bottles per day and this bact/alert sn broken bottle was the only one that leaked.Blood collection for this broken bottle was done in another hospital and transported to the customer¿s laboratory for testing.Cumitech 1c4 states that ¿blood culture bottles should be transported in a container that prevents them from falling, knocking into each other, or rolling off the surface.¿ the container and/or carrier device is a piece of equipment for the purpose of maintaining the integrity of the blood culture bottle containing the patient sample.It is unknown what type of container/carrier device was used to transport the culture bottle from the hospital to this customer¿s site, if the container/carrier device was adequately padded to protect the culture bottle from damage if dropped or subjected to excessive mechanical compression impact or force, or what type of courier service was used to transport the culture bottles to the laboratory (e.G.Car, van, truck, rolling cart through connecting hallways from hospital to laboratory (if applicable).The customer confirmed that the culture bottles were transported to the laboratory from another hospital site; however, information was not known on the type of container/carrier device used for transport, if adequate protective padding was in the container/carrier device, or the method of transport of the culture bottles to the laboratory (e.G.Vehicle, rolling cart).Device history record and complaint trends: queries of manufacturing data and review of manufacturing records for the bact/alert sn lot did not reveal any adverse trends relating to the presence of cracked bottom (broken bottle) in the bact/alert culture bottles.Queries on complaint data showed a trend for error code b101- broken bottle; however, no adverse trend is present for sn blood culture bottles.Conclude product compliance to specification/performance: there is no evidence of any bottle malfunction with the bact/alert sn culture bottle lot.Monitoring and detection methods for identifying bottle defects are part of the manufacturing and quality control processes for bact/alert culture bottles.The investigation confirmed that the bottles are susceptible to mechanical breakage if dropped and/or encountered compression impact at certain heights/angles of falling.Bottles will crack with certain impacts; however, will not shatter into many pieces (shatter resistance) as a safety feature.The customer was provided with adequate references in the instructions for use (ifu) and the bact/alert 3d user manual for information on visually inspecting bottles before inoculation, and before loading bottles into the instrument.The customer confirmed that the culture bottles were transported to the laboratory from another site.Customers are responsible for protecting the integrity of container and/or carrier devices that transport patient samples for clinical testing.Cumitech 1c blood cultures iv, asm press, 2005 (cumitech 1c4) is referenced in the ifu for bact/alert sn.Advice and recommendations for lcs/customer based on ifu/instrument manual/testing (if applicable): the investigator reviewed the instructions for use [ifu] for bact/alert culture bottles and the bact/alert 3d user manual which provides guidance pertaining to bottles exhibiting damage (e.G.Cracked bottom): visually inspect bottles before inoculation and testing visually inspect bottles before loading into instrument and if the bottle is cracked, do not load the bottle a cracked bottom of the bottle has the potential to expand when exposed to heat and cause potential leakage do not use bottles that show evidence of damage, leakage or deterioration a crack pattern (e.G.¿star-like¿) on the bottom of a bottle indicates the bottle encountered impact with a hard surface handle the bottles that are received and unpacked in a manner that prevents physical damage or impact report bottles that have been dropped during inoculation and/or transport to the laboratory make sure transport containers are well padded for transport of bottles, wrap each bottle individually to prevent any impacts with any other items in the carrier verify capacity limit of culture bottles in a transport container to ensure integrity of patient samples during transport to the laboratory always wear gloves and other personal protective equipment (gowns, glasses, shields, etc.) when handling inoculated blood culture bottles train staff to notify the laboratory of any bottle that is known to have been dropped or mishandled.Customer service provided the customer letter in (b)(4) bact/alert®plastic bottle impact testing to the customer.
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