MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® SA (PLASTIC)

Catalog Number	259789
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During biomérieux fse (field service engineer) intervention at a united states customer site, the fse identified dried blood inside the customer's instrument on all drip trays within the instrument.The fse stated the customer does not pad tube carriers when using the tube station for transporting bact/alert blood culture bottles.The fse asked to the customer if they have ever identified a broken bottle, and the customer stated they have not.In this case, there was a potential safety hazard from blood spill(s).Biomérieux instructed the customer to clean the dried blood wearing personal protective equipment (ppe).There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health, nor the health of the user(s).Biomerieux will initiate an internal investigation.
Additional Manufacturer Narrative
Context: an investigation was initiated in response to a complaint from a field service engineer (fse) at (b)(6) medical center, (b)(6) usa (cn-(b)(4)).Biomérieux was notified on 15jun2021 (contact date) of finding dried blood on all the drip trays in their bact/alert 3d instrument at this customers site.The fse provided a photo of bact/alert sa (has a standard flip cap-blue) and sn (has a standard flip cap-garnet) culture bottles loaded in the instrument with dried blood stains on the drip tray.The photo also showed a blood spot on a bact/alert sa culture bottle and it appeared to have dripped onto the drip tray.The reagent lot numbers used by the customer were not communicated by the customer.The scope of this investigation is to evaluate the leaking of blood from the bact/alert culture bottles onto the bact/alert 3d instrument drip trays.Risk assessment: it was reported that a customer had dried blood on the bact/alert 3d instrument used in association with bact/alert culture bottles.No impact/harm to patients/users since the customer did not find blood leaking from the bottles prior to loading bottles into the instrument.The impact to customer is the cleaning of the dried blood areas in the 3d instrument with appropriate biohazard procedures.There was no patient harm reported.Root cause analysis: monitoring and detection methods are in place to detect the presence of misaligned and/or damaged stoppers that could potentially cause leaky septums of bact/alert culture bottles.The instruction for use (ifu) for the bact/alert sa provides adequate guidance and reference to an associated document to reduce the chance of improper blood collection practices for culture bottles.Monitoring of equipment performance occurs during the manufacture of bact/alert culture bottles.The poor condition of the drip trays on the bact/alert 3d instrument is a result of leaky culture bottle septums that were submitted to the laboratory at the customer¿s site for testing.Environmental monitoring occurs on a routine basis in the manufacturing facility for bact/alert culture bottles and also did not contribute to the root cause of this investigation.Based on the root cause evaluation, there were two most probable root causes: materials and manpower, for leaky culture bottles pertaining to the complaint.- material root cause: a photo from the customer¿s site showed a bact/alert sa culture bottle (has a standard flip cap-blue) with a blood drip on the middle of the septum and blood spots on the drip tray.The field application specialist during a customer onsite visit confirmed that the hole in the septum of some of the culture bottles was larger than normal.Inoculated bact/alert culture bottles were transported to the laboratory from different locations at the customer¿s site.It was commented that two of the sites were using different types of adapter caps for the blood collection into bact/alert culture bottles.The brooklyn ed (emergency department) used the saf-t holder adapter cap from smiths medical and the outpatient clinic used the monoject¿ collection device-male.The laboratory was able to confirm that the bottles showing the leakage came from one location (not revealed by customer) and reached out to the providing locations to ensure the correct adapter caps were being used to inoculate the bact/alert culture bottles.An adaptor cap is used as an aid in conjunction with a butterfly blood collection set to assist in the filling of blood into a bact/alert culture bottle.It also helps protect the user from needle-stick injuries during the blood collection process.The adapter cap might or might not have a luer.This component has a retractable rubber sheathing over the part of the needle that would penetrate the septum of the bact/alert culture bottle.The adaptor cap with no luer is connected to a butterfly blood collection set with a double pointed needle; one end punctures the patient¿s skin and the other needle has the rubber retractable sheathing over it (luer) that when securely inserted into the adaptor cap would penetrate the septum of the bact/alert culture bottle.The two adaptor cap types used at two locations at the customer site have an attached luer: monoject¿ collection device-male and saf-t holder®blood culture device-male luer adapter.These adaptor cap types provide an allowable connection to different butterfly collection sets; however, combining components from different manufactures can create a problem during use.If the connection between the butterfly collection set and adaptor cap is not secure, there is a chance of losing vacuum needed for the blood to flow freely into the culture bottle.The adaptor cap recommended by biomérieux for use with the bact/alert blood culture bottles is the itl samplok® adapter cap 3 (reference a100760).The user would attach a butterfly collection set with a double pointed needle by screwing the end with the rubber retractable sheathing over the needle into the opening at the top of the adapter cap until tightly secured.This configuration provides a seamless vacuum pathway for the blood to flow freely into the bact/alert culture bottles.Bact/alert culture bottles with blood drips in the middle of the septum came from a specific location at the customer¿s site.The issue was believed to be caused by the blood collection devices used by the department sending the ¿leaky bottles¿ to the laboratory.- manpower root cause: the customer was able to identify the location from which the leaky culture bottles were originating and nurse educators went to the location to retrain personnel on proper blood collection for culture bottles.The manager for the customer contact with biomérieux communicated that the submission of leaky culture bottles to the laboratory did not re-occur and the issue has been resolved with the retraining of personnel.Details of the retraining were not communicated to biomérieux.Blood culture bottles should be checked by the laboratory personnel when received and again prior to loading the culture bottles into the bact/alert 3d instrument.The appearance of leaky culture bottles was not reported by the laboratory.The evidence of the leaky culture bottles was found after the bottles have been loaded into the 3d instrument: blood spots on the drip tray and blood drips on some of bottle septums.Device history record and complaint trending: queries of manufacturing data and for the bact/alert product did not reveal any adverse trends relating to biological exposure hazard to user due to finding dried blood spots on bact/alert 3d instrument drip trays from bact/alert culture bottles with leaky septums.A query for complaint error code on safety hazard due to finding dried blood spots on bact/alert 3d instrument drip trays from bact/alert culture bottles with leaky septums was performed.The investigator concluded the analysis of the complaints returned on the query revealed no adverse trend is present for bact/alert product.Conclusion on product compliance to specification and performance: there is no evidence of any bottle malfunction with the bact/alert culture bottle lots.No specific lot numbers were communicated to biomérieux by the customer; however, monitoring and detection methods are inherent to manufacturing processes for bact/alert culture bottles to identify any potential bottle defects that occur as a result of the manufacturing processes.Biomérieux customer service recommended that local representatives should document needle brand, part number, batch number, size, and length for all complaints related to blood culture bottle inoculation and leaking.All devices used in the blood culture collection should be documented for brand and batch, adapter caps, catheter line draws, syringes, etc.Very large bore needle devices <18 gauge should be avoided, as they may core the stopper and prevent resealing of the inoculation hole.

• Brand Name: BACT/ALERT® SA (PLASTIC)
• Common Device Name: BACT/ALERT® SA (PLASTIC)
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• Manufacturer (Section G): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12159718
• Report Number: 3002769706-2021-00022
• Device Sequence Number: 14627739
• Product Code: MDB
• UDI-Device Identifier: 03573026055806
• UDI-Public: 03573026055806
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K020931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 259789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown