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Intended use: bact/alert® fn plus culture bottles are used with the bact/alert® microbial detection system in qualitative procedures for recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids.Description of the problem: a customer in (b)(6) notified biomérieux of accidental blood exposure due to cracked bottle with bact/alert fn plus (plastic) (ref.410852, batch number 0004056536, expiration date 03-nov-2021).It is understood that the customer had blood on her hand as she was not wearing the appropriate personal protective equipment (ppe), "when taking the cracked bottle out of bta, customer had a little blood on her hands (because she was not wearing a glove) but she had no wounds on her hands and she washed her hands immediately." it was also reported that the cracked bottle was flagged as positive but that the smear and subculture were both negative and the aerobic bottle pair collected at the same time was also negative.There is no indication or report from the customer that this event led to any adverse event related to the patient's or user's state of health.An investigation will be initiated.
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A customer in france notified biomérieux of accidental blood exposure due to cracked bottle with bact/alert® fn plus (plastic) (ref.410852, lot# (b)(6), expiration date 03-nov-2021).The cracked bottle allowed blood to leak.The blood passed under the sensor and into the cell of the bact/alert® 3d instrument during incubation.A photo of the broken bottle was provided.The crack on the bottom of the bottle shows a ¿star-like¿ pattern which is indicative of the bottle withstanding some type of an impact.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.The customer communicated that when the analyst removed the bottle from the bact/alert 3d instrument, there was a little blood on the ungloved hand.The analyst had no wounds on the hand and washed hands immediately.Investigation: local customer service (lcs) verified 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.Global customer service (gcs) informed lcs regarding impacts to bottles as per the customer service notification (csn) 5292-bact/alert®plastic bottle impact testing.Retain product testing: three hundred (300) bottles from fn plus lot 0004056536 were inspected for evidence of cracks on the bottom of the bottle.No broken, cracked, or leakage bottles were found during this inspection.Based on the evaluation of data, using the ishikawa method, three root causes were identified for the presence of a ¿star-like¿ pattern on the bottom of the bact/alert fn plus culture bottle pertaining to complaint inv-5691: 1) a graph of the broken bottle was provided by the customer and attached to the complaint case (b)(4)).The bottle flagged positive by acceleration algorithm after 1.64 days of incubation.The graph associated with the bottle looks very jagged in appearance; an indication of a lot of noise (disturbance).This graph is consistent with bottles encountering an impact sometime prior to loading into the instrument.2) the customer is provided with adequate references in the ifu and the bact/alert user manual for information on visually inspecting bottles before inoculation, and before loading bottles into the instrument.The customer did not inspect the bottles for any cracks prior to loading the bottles into the bact/alert 3d instrument.The ifu also cautions the user to handle the bottles with gloves to avoid possible exposure to biological hazards.3) the inoculated bact/alert fn plus bottles were transported to the laboratory by way of the pneumatic tube system.It is advised to load the transport container with tubes/culture bottles in a way to prevent damage to the specimens while in transport through the pneumatic tube system as per cumitech 1c4 (referenced in the bact/alert fn plus ifu).Information pertaining to the quantity of bottles placed in the transport container (e.G.More than two bottles), or the evidence of adequate padding for the bottles within the transport container was not communicated.Carriers are specifically made to transport biohazard materials (e.G.Blood or laboratory specimens).Carriers have a full perimeter seal (either top or side loading versions) to protect against accidental spills within the tube system.Carriers are designed to hold an allowable weight capacity that can travel through the tube system at a certain speed and distance.Containment materials (e.G.Foam inserts) can be placed inside the carrier to ensure safe transport of materials.It is unknown if the customer performed a study of their pneumatic tube system as recommended by cumitech 1c blood cultures iv, asm press, 2005 (cumitech 1c4).Cumitech 1c4 advises that a pneumatic tube system should be tested to identify what harsh conditions could tubes/culture bottles withstand during transportation within the pneumatic tube system.Device history record and complaint database review: the investigator reviewed the manufacturing records for the bact/alert fn plus lot.This review did not reveal any adverse trends relating to the presence of cracked bottom (broken bottle) in the bact/alert culture bottles.A search for similar complaints showed no adverse trend is present for the error code b244-broken bottle-pneumatic tube for blood culture bottles.Conclusion: there is no evidence of any bottle malfunction with the bact/alert fn plus 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 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 by way of a pneumatic tube system and upon arrival to the laboratory, only the volume of the blood in the bottle was checked and not inspected for any possible damage (e.G.Cracks).Cumitech 1c4 advises that a pneumatic tube system should be tested to identify what harsh conditions could tubes/culture bottles withstand during transportation within the pneumatic tube system.The capacity limit of bottles and adequate padding in the transport container traveling through a pneumatic tube system is the responsibility of the customer to verify the integrity of the specimens upon arrival to the laboratory.The investigator reviewed with the customer 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 will tend to expand when exposed to heat and cause potential leakage.¿ discard bottles that show evidence of damage, leakage or deterioration.A ¿star-like¿ crack pattern 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 through a pneumatic tube system, 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 through a pneumatic tube system.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.
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