MAUDE Adverse Event Report: ETHICON INC. J-VAC RESERVOIR 450 ML; 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	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.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: was surgery delayed due to the reported event? unknown.Was procedure successfully completed? unknown.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.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.What is the lot number? please clarify, what did you mean by the drain spring did not work? can you please elaborate on the quality issue experienced with the product? please clarify which component failed (blake drain or jvac reservoir)? if the blake drain presented any quality issues, please provide corresponding product code and lot number.Was the reservoir used in the patient? was the issue noticed before activating the reservoir? did the reservoir function properly upon first activation? if yes, how long after the first activation happened did the issue occur? is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.Please provide the source or name and title of external person providing answers to follow-up.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 an unknown date and a reservoir was used.The drain spring did not work.Additional information has been requested.
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.Additional information: d4, d9, h3, h4, h6.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional h6 component code: g07002 no device problem.Additional h3 investigation summary: man tie too long.During sample evaluation the plate was able to be open and close without any issue.The strap did not interfere on the correct function of the locking mechanism.Therefore, is considered this man factor does not contribute to the reported complaint defect.Materials damaged/ broken component locking mechanism of reservoir was checked to verify its condition.Sample was evaluated, and during this evaluation it was notice that the latch of plate and its mechanism were in good conditions; the plate was able to be open and close.In addition, plate subassembly needs to be properly closed in order to perform final assembly on finish good.Therefore, is considered this materials factor does not contribute to the reported complaint defect.Based on the present analysis, and condition of sample received it is determined that the reported complaint is not confirmed and it is not related to the manufacturing process and other external causes could have affected the product integrity such as handling, non-proper usage or any other possible contributor out of the manufacture control.

• Brand Name: J-VAC RESERVOIR 450 ML
• 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: 23123118
• Report Number: 2210968-2025-10869
• Device Sequence Number: 9352482
• Product Code: JOL
• UDI-Device Identifier: 10705031003316
• UDI-Public: (01)10705031003316(17)271130(10)JU0756
• 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): 11/13/2025

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: JU0756
• 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: 09/06/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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