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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA API® NIN-2

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BIOMERIEUX, SA API® NIN-2 Back to Search Results
Catalog Number 70491
Device Problem Fluid Leak (1250)
Patient Problems Skin Discoloration (2074); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Biomérieux conducted an internal investigation: verification of retention kit batch n°1005510500: conform (no breakage or leakage of the reagent). Verification of the packaging: the packaging is compliant in accordance with the internal manufacturing procedure: "each nin corked vial had to be placed in a ampule protector then packaged pointing down". Verification of the information mentioned in the package insert: hazard statements are mentioned with the signal word of symbols visible on the nin kit. Thus, precautionary statements are also mentioned including p280 phrase: "wear protective gloves/protective clothing/eye protection/face protection". The p302+p352 phrases describe the first aid measures: if on skin: wash with plenty of soap and water. This information is also available on page 9 in the warnings and precautions: "refer to the hazard statements "h" and the precautionary statements "p" indicated above. " verification of the information mentioned in the msds sheet ref. (b)(4); section 2 hazard identifications. 4 first aid measures: skin contact: flush with copious amounts of water for at least 15 minutes. Remove contaminated clothing and shoes. Summon doctor. 8 exposure control: hand: wear suitable gloves (nitrile rubber). Skin and body: wear suitable protective clothing. In conclusion, all measures are in place in order to advise and alert customers to reagent toxicity. According to the information available, this issue is probably due to leakage or breakage of the reagents in the kit during the shipment. Customers are instructed to check the appearance of the product before transferring it into the dropper-bottles. Documents available in the technical library, that is to say the package insert v (b)(4) and the msds sheet rev. D mention information linked to hazard statements (sections r and s), precautionary measures (section p), the first aid measures and the behavior in case of exposure control, especially to wear suitable protective clothing and gloves. Thus, according to the information available, this issue is probably due to leakage or breakage of the reagents in the kit during the shipment. In conclusion, all measures are in place in order to advice and alert customers to reagent toxicity.
 
Event Description
A customer from (b)(6) reported to biomérieux exposure to reagent liquid due to leakage of api® nin-2. The customer reported that their fingers turned purple when opening the box, and that the bottom right hand corner of the white box was brownish in color. The customer did not use the product. There is no indication or report from the customer that the exposure led to any adverse event related to the user's state of health. Biomérieux requested additional information from the customer as api® nin-2 is toxic when in contact with skin. There has been no response from the customer. A biomérieux internal investigation will be initiated.
 
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Brand NameAPI® NIN-2
Type of DeviceAPI® NIN-2
Manufacturer (Section D)
BIOMERIEUX, SA
3 route de port michaud
la balme les grottes isere, 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme les grottes isere, 38390
FR 38390
Manufacturer Contact
ellen weltmer
595 anglum road
st. louis, MO 63042
3147317301
MDR Report Key6824790
MDR Text Key260699108
Report Number3002769706-2017-00252
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
C1 EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/21/2018
Device Catalogue Number70491
Device Lot Number1005510500
Other Device ID Number03573026141974
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2017
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/28/2017 Patient Sequence Number: 1
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