MAUDE Adverse Event Report: ETHICON INC. J-VAC*RESV. 150 ML; CATHETER AND TIP SUCTION

Model Number	2161
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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.
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2019 and a reservoir was used connected to a drain.Scrub nurse could not activate the reservoir.It would not lock into place.The device just popped back open, and was unusable.When a second reservoir was opened, it worked perfectly.No patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Evaluation: sample was received and evaluated and no damaged/broken components that could relate to the defect reported by customer could be observed.Sample was found in good condition.Plate was able to be opened and closed several times.Defect is not duplicated, since plate was able to be open and close without any issue.Defect reported by customer not replicated.Plate was able to be opened and closed several times on sample reviewed.Based on the present analysis, it is determined that the reported complaint is not duplicated and is not related to manufacturing process and other external causes could have affected the product integrity such as handling, non-proper usage or any other possible contributor out of the manufacturer control.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to fda: 8/25/2020.

• Common Device Name: CATHETER AND TIP SUCTION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8458977
• Report Number: 2210968-2019-79757
• Device Sequence Number: 3558853
• Product Code: JOL
• UDI-Device Identifier: 10705031003309
• UDI-Public: 10705031003309
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K953655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 2161
• Device Catalogue Number: 2161
• Device Lot Number: JT8792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/17/2019; 08/17/2020
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/15/2019; 08/25/2020
• Patient Sequence Number: 1