MAUDE Adverse Event Report: ETHICON INC. J-VAC* RESV. 450 ML; CATHETER AND TIP SUCTION

Model Number	2162
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What do you mean by poor internal hygiene? was there any foreign matter found on the product inside of the packaging? if yes, please describe what was found? or was the integrity of the packaging compromised in any way? any hole tear or puncture observed causing the poor hygiene?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and a reservoir was connected to a drain.It was reported that there was inadequate vacuum mechanism and poor internal hygiene.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: what do you mean by poor internal hygiene? has any foreign material been found on the product inside the package? it was not reported has the integrity of the packaging been compromised in any way, any hole or perforation observed causing poor hygiene? not informed by client.The product has been discarded by the customer, will not be sent for analysis.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• 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: 8226486
• Report Number: 2210968-2019-78259
• Device Sequence Number: 1218013
• Product Code: JOL
• UDI-Device Identifier: 10705031003316
• UDI-Public: 10705031003316
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: CL II EXEMPT
• 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): 12/12/2018

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: 06/30/2023
• Device Model Number: 2162
• Device Catalogue Number: 2162
• Device Lot Number: JT8763
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 08/17/2020
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 01/16/2019; 09/09/2020
• Patient Sequence Number: 1