MAUDE Adverse Event Report: ETHICON INC. J-VAC; CATHETER TIP SUCTION

Catalog Number	2160
Medical Device Problem Codes	Leak/Splash (1354); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.The following information was requested but unavailable: what is the lot number of the 2160 reservoir bulb involved? unk what is the lot number of the 2227 blake drain involved? unk did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? unk was a new drain needed to correct the situation? if so, was the new drain implanted surgically during a second procedure? unk please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.We regularly contact with sale rep about the device returning.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and a reservoir was used.During the procedure, the drainage was leaked, and the reservoir could not be used.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d9.H3 evaluation: product sample received for analysis.Complaint sample review: one complaint sample of reservoir bulb with pre-attached adapter was received for evaluation, product was inspected visually as well as functionally and in reference to the complaint details -no negative observation was identified (video of functional test).As per standard practice, 100% functional test and 100% visual inspection was carried out, before and after packing of finished goods, prior to the product release.There was no scope to miss such defect, at manufacturing / release stage.Documents review: lot not provided.Retention sample review: lot not provided.Review of defective sample's image / video: not applicable, as there was no complaint sample image / video received for evaluation.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: J-VAC
• Common Device Name: CATHETER TIP SUCTION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA INDIA; 251, sector-6, imt manesar; gurugram 12205 2; IN 122052
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23742530
• Report Number: 2210968-2025-13667
• Device Sequence Number: 10464116
• Product Code: JOL
• UDI-Device Identifier: 10705031003293
• UDI-Public: 10705031003293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CL II EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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 Catalogue Number: 2160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 03/08/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown