NUCLISENS? EASYMAG? DISPOSABLE 280135

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-02-23 for NUCLISENS? EASYMAG? DISPOSABLE 280135 manufactured by Biomerieux Sa.

Event Text Entries

[101142287] A biom? Rieux internal investigation was performed. A vessel was visually inspected, and a plastic split on the first well of the vessel was observed. The investigation with the supplier determined there was an issue either during inspection of the pieces or during transportation of packaged disposables. As a corrective action, the supplier will update the packing handling symbols on the outer boxes of the nuclisens? Easymag? Disposable in order to implement a careful handling of the products during shipment. In addition, the supplier will dispense a specific training to the teams working at each step of the nuclisens? Easymag? Disposable manufacturing. The goal will be to clarify the nonconforming products detection and the appropriate actions to implement during manufacturing.
Patient Sequence No: 1, Text Type: N, H10


[101142289] A biom? Rieux employee reported a problem with the nuclisens? Easymag? Disposable (lot z108lc). The employee reported a leakage issue with the first well of the vessel during extractions. The customer stated other vessels in the batch were not pierced. There were no patients involved with this issue. There is no indication from the laboratory that the leaking vessel led to any adverse events related to the user; however, there was unexpected leakage of sample/reagent contents.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002769706-2018-00022
MDR Report Key7293605
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-02-23
Date of Report2018-02-23
Date Mfgr Received2017-09-05
Device Manufacturer Date2007-05-29
Date Added to Maude2018-02-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactELLEN WELTMER
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147317301
Manufacturer G1BIOMERIEUX SA
Manufacturer Street5, RUE DES BERGES
Manufacturer CityGRENOBLE CEDEX 01, 38024
Manufacturer CountryFR
Manufacturer Postal Code38024
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUCLISENS? EASYMAG? DISPOSABLE
Generic NameNUCLISENS? EASYMAG? DISPOSABLE
Product CodeJJH
Date Received2018-02-23
Catalog Number280135
Lot NumberZ108LC
Device Expiration Date2018-10-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX SA
Manufacturer Address5, RUE DES BERGES GRENOBLE CEDEX 01, 38024 FR 38024


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-23

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