MAUDE Adverse Event Report: BIOMERIEUX, INC BACT/ALERT® SN CULTURE BOTTLE

Catalog Number 259790

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in canada contacted biomerieux to report a cracked bact/alert sn culture bottle.The bottle was loaded anonymously, and when the user accessed the bottle to id it, the user noticed the bottle had leaked a minimal amount of blood and media solution into the instrument cell where the bottle was placed.The user removed the bottle using standard precautionary measures and protective lab equipment; the user was not in direct contact with the blood.The bottle was (b)(6) to date.The user cleaned the cell, and a new specimen was requested to replace the bottle; delay less than 24 hours.It is unknown if the bottle was received by the customer in a cracked condition, or if the customer's pneumatic tube system caused the bottle damage.Photos indicate the appearance of the crack is consistent with an impact fracture.There is no indication or report from the laboratory that the bottle leakage led to any adverse event related to the user's state of health.There is no indication or report that the incurred delay in reporting results had adverse impact to the patient's state of health.Biomerieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report a cracked bact/alert® sn culture bottle.An internal biomérieux investigation was performed.The investigation examined the bact/alert® sn lot 3046077 packaging inspections, including the quality acceptable quality limit inspection documentation, and all the results were within specification.Quality assurance subsequently released the lots for distribution to the field on 17may2016.Retained samples from lot 3046077 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® sn 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 3046077 produced 234,600 bottles and has one 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® SN CULTURE BOTTLE
• Type of Device: BACT/ALERT® SN CULTURE BOTTLE
• 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6086689
• MDR Text Key: 59463117
• Report Number: 3002769706-2016-00467
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021123
• 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: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2017
• Device Catalogue Number: 259790
• Device Lot Number: 3046077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1