AQUA-SEAL CDU 8888571299

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-16 for AQUA-SEAL CDU 8888571299 manufactured by Covidien.

Event Text Entries

[184630653] (b)(4). The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10


[184630694] The customer reported that the pleurovac does not vacuum/suction. The customer reported patient injury as superior vena cava syndrome. No additional information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611018-2020-00419
MDR Report Key9835858
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-02-17
Date Mfgr Received2020-02-18
Date Added to Maude2020-03-16
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer StreetSRAGH INDUSTRIAL ESTATE, CO, T
Manufacturer CityOFFALY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAQUA-SEAL CDU
Generic NameBOTTLE, COLLECTION, VACUUM
Product CodeKDQ
Date Received2020-03-16
Model Number8888571299
Catalog Number8888571299
Lot Number19B054FHX
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressSRAGH INDUSTRIAL ESTATE, CO, T OFFALY EI


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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