MAUDE Adverse Event Report: BIOMERIEUX, INC BACT/ALERT FN; BACT/ALERT® FN

Catalog Number 259793

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a blood culture sample clotting in association with the bact/alert® fn plastic bottle (reference # 259793, lot # 0001055186).The initial complaint from the customer mentioned a bottle received without agar present.This was noticed by the technician prior to loading the bottle in the instrument and a second sample was able to be taken without causing a delay.There was no patient harm or impact.The customer later confirmed that the description of their initial complaint was supposed to be for a blood clot generated in the bottle.The sample had clotted in the impacted bottle.The customer stated that an on-site investigation found the clotting issue was due to operator error rather than a product issue.The user did not shake the bottle evenly after collecting a blood sample.However, there are no instructions in the bact/alert bottle package insert requiring shaking or inverting the tube for collection.Rather, the bottles are constantly agitated when loaded in to the machine.It is possible that other steps in the blood sample collection process may have led to the sample clotting.The customer noted that they directly collected blood from the ¿elbow vein¿ through a butterfly needle.Depending on the gauge size of the needle it is possible to slow the flow, and this could contribute to clotting.However, the size of the needle has not yet been confirmed by the customer.Regarding media in the bottle, biomérieux¿s cross functional team confirmed that the sps anticoagulant in the bottle media is added in bulk (large batches), and not likely to be missing or reduced in any one bottle.The complaint data supports this, as there are no other complaints for clotted bottles at this time.The customer confirmed that there was no patient harm or impact as a result of this event.There was no reported delay.There were no incorrect results obtained by the bact/alert reagent or instrument.Additional troubleshooting information has been requested by customer service.The customer is unable to provide pictures of the impacted bottle.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in china regarding a blood culture sample clotting in association with the bact/alert® fn plastic bottle (reference # 259793, lot # 0001055186).The customer stated that an on-site investigation found the clotting issue was due to operator error rather than a product issue.The user did not shake the bottle evenly after collecting a blood sample.However, there are no instructions in the bact/alert bottle package insert requiring shaking or inverting the tube for collection.Rather, the bottles are constantly agitated when loaded in to the machine.The bottle instructions for use (ifu), and training materials were reviewed by the investigator and found to have adequate directions for the user.Queries of the manufacturing data, and the complaint data do not reveal any adverse trend for any issue related to clotted bottles or bottles with the media volume absent.The lot is now expired and no similar complaints were received.Review of the manufacturing records show that the bact/alert® fn culture bottle lot 0001055816 met all quality control and release criteria; there was no evidence found that would contribute to a bottle with no media fill volume.Monitoring and detection methods for potential no media fill volume are part of the manufacturing processes for bact/alert® culture bottles.The following are possible root causes that can cause bact/alert fn bottle to have a clotted sample: -bottle was damaged before use and media leaked out.-patient diagnosis or treatment contributed to hypercoagulation.-use of small gauge butterfly needle (>=23 g) slowed down blood flow and contributed to coagulation (or use of butterfly needle without adapter cap vented vacuum and slowed down flow).The investigation did not find evidence that the bact/alert fn culture bottle lot 0001055816 was the root cause for the complaint issue, but there was insufficient information supplied from the customer to find the root cause.Biomérieux will continue to monitor similar complaints for this issue.See section h10.

• Brand Name: BACT/ALERT FN
• Type of Device: BACT/ALERT® FN
• Manufacturer (Section D): BIOMERIEUX, INC; 100 rodolphe street; durham NC 27712
• MDR Report Key: 11041752
• MDR Text Key: 251880438
• Report Number: 3002769706-2020-00020
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026055844
• UDI-Public: 03573026055844
• Combination Product (y/n): N
• PMA/PMN Number: K020815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

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: Health Professional
• Device Expiration Date: 02/06/2021
• Device Catalogue Number: 259793
• Device Lot Number: 0001055186
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1