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

Catalog Number 410852

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of a broken bact/alert® fn plus bottle when processed in a virtuo® instrument.The customer reported receiving an alert message giving notification that the bottle could not be removed from cell d18.The user noticed the bottle had leaked blood and media solution and was stuck in the instrument cell.The bottle was manually removed without exposure to the user.The bottle was empty and could not be cultured.The customer stated the second bottle from the same patient was negative, and the patient did not have sepsis.The customer reported patient results were not affected.Photos of the fn plus bottle indicate that the bottle was compromised prior to loading and the bottle bottom sustained an impact fracture.It is unknown if the bottle was dropped sometime prior to inoculation or it was cracked during the transportation in the pneumatic tube system.A biomerieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the investigation examined the bact/alert® fn plus lot 3047128 packaging inspections, including the quality acceptable quality limit inspection documentation, and the results were within specification.Quality assurance subsequently released the lots for distribution to the field on 10sep16.Retained samples from lot 3047128 were visually inspected by the investigator for any evidence of broken bottles.There were zero bottles found to be broken.The information outlined in the bact/alert® fn plus instructions for use (ifu) instructs the users "prior to use, the bact/alert culture bottles should be examined for evidence of damage or deterioration (discoloration).Bottles exhibiting evidence of damage, leakage, or deterioration should be discarded." a definitive root cause was not identified for this complaint investigation.There is no evidence of a systemic issue with the lot within the scope of this investigation.Lot 3047128 produced (b)(4) bottles and has one (1) complaint against it and is not believed to be a systemic issue.Customers should continue following the associated ifu and bottles should be examined for evidence of damage or deterioration (discoloration) prior to use.Bottles exhibiting evidence of damage, leakage, or deterioration should be discarded and not used.

• Brand Name: BACT/ALERT® FN PLUS
• Type of Device: BACT/ALERT® FN PLUS
• Manufacturer (Section D): BIOMERIEUX, INC.; 100 rodolphe street; durham NC 27712
• Manufacturer (Section G): BIOMERIEUX, INC.; 100 rodolphe street; durham NC 27712
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6392455
• MDR Text Key: 69574940
• Report Number: 3002769706-2017-00037
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K121455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2017
• Device Catalogue Number: 410852
• Device Lot Number: 3047128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1