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

Catalog Number 259790

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux, bottle leakage in association with the bact/alert® sn bottle.The customer reported that the sn bottle was flagged positive by the analyzer and the isolate was identified as clostridium perfringens.The customer stated that as positive bottles were being removed from the analyzer, the sn bottle leaked onto a bottle in the cell below and into the drawer.As the sn bottle was removed, it was full of gas so the bacteria and blood suspension came out through the rubber septum (via the inoculation hole).The customer stated the bottle was not at eye level and there was no exposure to the user's face.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.The customer reported standard collection procedures were used during inoculation.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the manufacturing directions of the involved lot was reviewed and met all release criteria.Historical review of this complaint event determined the event to be low occurring.High gas-producing organisms such as the isolates identified by the customer, clostridium perfringens, are a known hazard when enclosed in the bottle, as they can produce enough gas to cause the septum to bulge, and in rare cases, can leak through the inoculation hole or the crimp seal, if left incubating too long, post positivity.The customer used a 19 gauge needle to inoculate the bact/alert® sn bottle.Although there are no instructions provided in the bact/alert® sn instructions for use for the recommended needle size, in the clinical setting, 20 gauge needles are commonly provided with blood draw sets.The customer is cautioned not to use a needle larger than the standard 20 gauge size, as this, coupled with the high gas-producing organism, contributed to the event.In the complaint description the customer stated that because the bottle was not at eye level there was no exposure to the user's face.During the review of the ifu the investigation determined the ifu did not specifically instruct the user to wear face protection when handling the bact/alert® bottles.As a corrective action, the ifu will be updated with a safety precaution for users to wear proper personal protective equipment such as gloves, gowns, and face protection when handling any potentially infectious material.The root cause of this complaint was determined to be process related.

• Brand Name: BACT/ALERT® SN
• Type of Device: BACT/ALERT® SN
• 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: 6763288
• MDR Text Key: 82575791
• Report Number: 3002769706-2017-00223
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2017
• Device Catalogue Number: 259790
• Device Lot Number: 1047681
• Other Device ID Number: 03573026055813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2016
• 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