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

Catalog Number	2162
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.J-vac reservoir 450 ml (2162) : affected side: does not apply ## reason why the product is not available: discarded.J-vac reservoir 450 ml (2162) : lot/lot number: ju1321.List all j&j products that were used during the case but did not contribute to the reported event.The reservoir did not vacuum after the manipulation of the break, the indicated place to hold the drain was escaping the vacuum.As reported, after the reservoir was replaced, the vacuum was restored.Was there any damage or injury reported by the patient or user? no.Was there a significant delay ? no.If available, please provide the product order number (po).The photo upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.No product is available for return.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 an unknown procedure on (b)(6) 2026 and a reservoir was used.The reservoir did not make the vacuum after manipulating the break.They indicated to hold the drain was escaping the vacuum.According to the report, after changing the reservoir, the vacuum was restored.

• Brand Name: J-VAC
• Common Device Name: CATHETER AND TIP SUCTION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-FLEXTRONICS MEDICAL ; 1659 gailes blvd; san diego CA 92154
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25565262
• Report Number: 2210968-2026-06504
• Device Sequence Number: 13281154
• Product Code: JOL
• UDI-Device Identifier: 10705031003316
• UDI-Public: (01)10705031003316(17)300731(10)JU1321
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 2162
• Device Lot Number: JU1321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 06/26/2026; 09/02/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 07/13/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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