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

Catalog Number	2160
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information provided: lot-lab0011987v8: ethicon, affected side: both sides.Affected quantity: 1, available amount to be returned: 1.List all j&j products that were used during the case but did not contribute to the reported event.Surgery of the patient [redacted] [redacted], to perform a rhytidoplasty and rhinoplasty procedure with [redacted], when performing the placement of the j - vac drain, it was detected that the negative pressure was not working, and it was necessary to request the replacement of another j - vac reservoir.Drainage system j - vac / ref: 2160 lot: lab0011987v8 anvisa: (b)(4).Was there any damage or loss reported by the patient or user? no.Was there a significant delay? no.If available, provide the product order number (po).Surgery of the patient [redacted][redacted], to perform a rhytidoplasty and rhinoplasty procedure with [redacted], when performing the placement of the j - vac drain, it was detected that the negative pressure was not working, and it was necessary to request the replacement of another j - vac reservoir.Drainage system j - vac / ref: 2160 lot: lab0011987v8 anvisa: (b)(4).Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Did the reservoir bulb function properly upon first activation? if yes, how long after the first activation happened did the issue occurred? could you please confirm the lot number? could you please confirm the product code? could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.Please provide the source or name of person providing answers to follow-up questions: 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.
Event or Problem Description
It was reported a patient underwent a rhytidoplasty and rhinoplasty on (b)(6) 2026 and a reservoir was used.Upon placement of the drain, it was detected that the negative pressure was not functioning, and it was necessary to request replacement with another reservoir.Additional information has been requested.

• 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: 25031852
• Report Number: 2210968-2026-04632
• Device Sequence Number: 10260793
• Product Code: JOL
• UDI-Device Identifier: 10705031003293
• UDI-Public: 10705031003293
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 71 YR
• Patient Sex: Unknown