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	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2023 and a reservoir was used.The suction reservoir device has jammed.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.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 , patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? unkown.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.Did this issue contribute to any patient adverse event? were there any patient consequences? is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.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 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.Man 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 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 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 manufacturing control.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 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19382136
• Report Number: 2210968-2024-05545
• Device Sequence Number: 12347688
• Product Code: JOL
• UDI-Device Identifier: 10705031003316
• UDI-Public: 10705031003316
• 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,Followup
• Report Date (Section B): 06/28/2024

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: 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: 04/26/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 06/04/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/12/2024; 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2022
• 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