MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE

Catalog Number 410851

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of sample leakage in association with the bact/alert® fa plus culture bottle.The customer reported that one fa plus bottle was cracked near the bottom of the bottle, near the location of the sensor.The bottle had been sent to the lab using a pneumatic tube system without padding around the bottles.Blood leaked into the instrument, but no other blood culture bottles were contaminated by the sample.When removing the bottle, a lab technician was exposed to the leaking blood sample as she was not wearing gloves.The user's intact skin was exposed to the sample, and she washed her hands immediately.There was no medical treatment as a result of this exposure.There was no mucous membrane or cut on the user's skin that was exposed to the patient sample.The customer reported that the broken bottle was rejected for further testing and would be recollected from the patient.There is no indication of delayed results from the laboratory.The patient had another set of bottles being tested.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in the united states notified biomérieux of sample leakage in association with the bact/alert® fa plus culture bottle.The customer reported that one fa plus bottle was cracked near the bottom of the bottle, near the location of the sensor.When removing the bottle, a lab technician was exposed to the leaking blood sample, no medical treatment was required a result of this exposure.In response to the customer complaint biomérieux conducted an internal investigation.The investigation examined the bact/alert fa plus lot 4053188 packaging inspections, including the quality acceptable quality limit (aql) inspection documentation, and all the results were within specification.Three hundred (300) retain bottles from lot 4053188 were visually inspected for any evidence of broken bottles, no bottles were found to be broken.A historical review of complaint data was performed; no adverse trends were identified during the review.A review of documentation and pictures provided by the customer showed a star-like pattern on the bottom of the bottle, which is indicative of a dropped bottle.The customer stated a pneumatic system is used; however, it was confirmed that no padding is used for transportation of bottles.The bact/alert fa plus ifu states "visually inspect bottles before testing.Do not use bottles with evidence of damage, leakage, or deterioration." furthermore, the ifu also states "use disposable gloves and handle inoculated bottles cautiously as though capable of transmitting infectious agents.Consult a physician immediately if contaminated materials are ingested or come in contact with open lacerations, lesions, or other breaks in skin." the most probable root cause for this complaint event is the subject bottle was dropped before/during transport to the lab at the customer site.Although the customer did not report the bottle being dropped at any point, review of the photo showed a star-like break at the bottom of the bottle, which is indicative of a dropped bottle.The investigation found no evidence which suggests the manufacturing of bact/alert fa plus bottle lot 4053188 contributed to the bottle crack and subsequent exposure.

• Brand Name: BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE
• Type of Device: BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 8908017
• MDR Text Key: 188990425
• Report Number: 3002769706-2019-00050
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026357900
• UDI-Public: 03573026357900
• Combination Product (y/n): N
• PMA/PMN Number: K121461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

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: 02/26/2020
• Device Catalogue Number: 410851
• Device Lot Number: 4053188
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1