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

Model Number	2162
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
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.Attempts to obtain the device have been made.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 surgery on (b)(6) 2019 and a reservoir was used, at the time of connecting the reservoir it could not be activated.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/12/2020.Additional information: sample was not available for evaluation; therefore, reported event is not verified.However, it is documented, in addition, during manufacturing process each unit is activated to confirm proper function and inspected to confirm it complies with current manufacturing instructions.Based on the present analysis, the reported defect by the customer could not be evaluated.Or related to manufacturing process.In addition to, there was no sample available for evaluation.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to fda: 8/28/2020.

• Common Device Name: CATHETER AND TIP SUCTION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9553229
• Report Number: 2210968-2020-00117
• Device Sequence Number: 19613042
• Product Code: JOL
• UDI-Device Identifier: 10705031003316
• UDI-Public: 10705031003316
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/11/2019

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: 05/31/2024
• Device Model Number: 2162
• Device Catalogue Number: 2162
• Device Lot Number: JT8935
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/24/2020; 08/17/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/12/2020; 08/28/2020
• Patient Sequence Number: 1