MAUDE Adverse Event Report: ETHICON INC. J-VAC RESERVOIR 150 ML; CATHETER AND TIP SUCTION

Catalog Number	2161
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.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.Please clarify if there were consequences for the patient.Please perform and document the follow up attempt for product 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 a breast augmentation primary procedure on an unknown date and a reservoir was used.Post-op the bag started leaking from the seam five days after activation.No reported adverse consequences to the patient.Additional information has been requested.
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.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 evaluation: product sample received for analysis.Material: 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 condition.Plate was able to be open and closed with no issues observed.In addition, plate subassembly needs to be properly closed in order to perform final assembly in finish good.Therefore, is considered this materials factor does not contribute to the reported complaint defect.Man.In accordance with instructions for use (ifu) for this medical device, this is a suction reservoir, and it is designed to evacuate potentially detrimental collection of certain fluids from wounds in body cavities though its mechanism of suction.Therefore, in order to have a proper functionally and for the correct activation of this suction reservoir it is necessary that after drain tubing is connected to the port, start the suction by gently bending up the bottom flap, the unit will release, and suction will begin, in addition, an airtight seal between all system components (drain, adapter, and reservoir) is necessary for proper system function.To deviate the given indications is considered an inadequate usage of this suction reservoir.Therefore, it is considered that this man factor could have affected the product integrity and its function.Machine: welding around the ports and in the perimeter of the bag was inspected and it was found a breakage in the perimeter of the reservoir, confirming that it could be the cause of the leak.However, apparently reservoir seems to be used and deteriorate.It is possible that other external causes could have affected the product integrity such as handling or non-proper usage that are out of flex control.The complaint description indicates that it has been used for 5 days.Therefore, it is considered that machine 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 could be observed since it was found a breakage in the perimeter of the reservoir, confirming that it could be the cause of the leak.However, apparently reservoir seems to be used and deteriorated.It is possible that other external causes could have affected the product integrity such as handling or non-proper usage that are out of control.In addition, during manufacturing process, unit is activated to confirm proper function and inspected to confirm it complies with current manufacturing instructions.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 RESERVOIR 150 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18041529
• Report Number: 2210968-2023-08401
• Device Sequence Number: 7465998
• Product Code: JOL
• UDI-Device Identifier: 10705031003309
• UDI-Public: 10705031003309
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 03/08/2024

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: 2161
• Device Lot Number: JU0754
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 11/11/2023; 02/20/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/08/2023; 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 75 KG