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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT PF PLUS (PLASTIC); BACT/ALERT® PF PLUS (PLASTIC)

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BIOMERIEUX INC. BACT/ALERT PF PLUS (PLASTIC); BACT/ALERT® PF PLUS (PLASTIC) Back to Search Results
Catalog Number 410853
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Based on the evaluation of data and limited information provided by the customer, the most probable root cause for contamination of the bact/alert® pf plus culture bottle with paenibacillus provecensis is human error (bottle handling) by the customer.Bact/alert® pf plus culture bottle instructions for use (ifu) ¿bottle preparation¿ section states "prior to inoculation, the culture bottle top needs to be disinfected with an alcohol swab or equivalent and allowed to dry." the contaminant (paenibacillus provecensis) found in the bact/alert® pf plus culture bottle at the customer site is a gram positive spore-forming rod, primarily found in the environment and is known to be a common blood culture contaminant, per published literature.Use of one disinfectant prep per bottle top aids in the removal of spores which are resistant to disinfectants.The mechanical wiping action of the disinfectant prep picks the spores up off the bottle stopper.In addition, the bact/alert® pf plus culture bottle ifu states care must be taken to prevent contamination of a venipuncture during inoculation into the culture bottles (e.G.Proper skin disinfection).Cumitech 1c 4 for the proper specimen collection techniques (referenced in the instructions for use) stresses that the disinfection of the venipuncture site is very important in order to reduce contamination.Contamination could lead to a specimen being determined positive when a clinically relevant isolate is not actually present.This situation occurred with the customer samples resulting in false positives by the contaminant of paenibacillus provecensis.There is no evidence of any bottle malfunction with the bact/alert® pf plus culture bottle lot.Monitoring and detection methods for potential bottle contamination are part of the manufacturing and quality control processes for bact/alert® culture bottles.The quality control bioburden results for bact/alert® pf plus lot 0004054746 were within the cfu/ml final release specifications.There is no indication that the manufacturing process of bact/alert® pf plus lot 0004054746 culture bottles contributed to the contamination issue as per the complaint by the customer.
 
Event Description
A customer in (b)(6) notified biomérieux of contamination with paenibacillus provecensis in association with the bact/alert® pf plus (plastic) culture bottle (ref.410853, lot 0004054746) when testing blood culture.There is no indication or report from the laboratory that the contamination result led to any adverse event related to any patient's state of health.In response to the customer complaint biomerieux conducted an internal investigation.
 
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Brand Name
BACT/ALERT PF PLUS (PLASTIC)
Type of Device
BACT/ALERT® PF PLUS (PLASTIC)
Manufacturer (Section D)
BIOMERIEUX INC.
100 rodolphe street
durham NC 27712
Manufacturer (Section G)
BIOMERIEUX INC.
100 rodolphe street
durham NC 27712
Manufacturer Contact
jennifer armstrong
595 anglum road
hazelwood, MO 63042
MDR Report Key11553164
MDR Text Key246770558
Report Number3002769706-2021-00002
Device Sequence Number1
Product Code MDB
UDI-Device Identifier03573026357924
UDI-Public03573026357924
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K121446
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/23/2021
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 Date11/07/2020
Device Catalogue Number410853
Device Lot Number0004054746
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/22/2021
Initial Date FDA Received03/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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