J-VAC*RESV. 150 ML 2177

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 2020-01-27 for J-VAC*RESV. 150 ML 2177 manufactured by Ethicon Inc..

Event Text Entries

[177192550] (b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. The following information was requested and the following was obtained: did the reservoir inflate quickly upon activation? Yes. Was leakage detected? If so, where? No further information is available. Or was there a failure of the locking plate mechanism due to which the reservoir swelled immediately? No further information is available. No further information will be provided. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10


[177192551] It was reported a patient underwent a laparoscopic cholecystectomy on (b)(6) 2020 and a reservoir was used. After lifting the bottom flap, the reservoir swelled immediately, thus, suction could not be done. The reservoir was reconnected to the drain, but the same issue occurred. So, the reservoir was replaced to another one, then, suction could be done after bending up the bottom flap. Further details are not provided. No sample will be returned. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-00731
MDR Report Key9634151
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-27
Date of Report2020-01-07
Date of Event2020-01-06
Date Mfgr Received2020-01-07
Device Manufacturer Date2019-06-18
Date Added to Maude2020-01-27
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 ContactKARA DITTY-BOVARD
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone6107428552
Manufacturer G1ETHICON INC.-FLEXTRONICS MEDICAL
Manufacturer Street1659 GAILES BLVD
Manufacturer CitySAN DIEGO CA 92154
Manufacturer CountryUS
Manufacturer Postal Code92154
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJ-VAC*RESV. 150 ML
Generic NameWOUND DRAINAGE SYSTEM
Product CodeKOG
Date Received2020-01-27
Catalog Number2177
Lot NumberJT8925
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-27

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