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

Model Number	2161
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? lot ju0535.Please clarify what is the quality issue experienced? - the product did not maintain a vacuum condition.Was the product used on the patient? - senology surgery.Was another reservoir used to correct the situation? were there any patient consequences? if so, was there any associated medical or surgical intervention? is the reservoir available to be returned for evaluation? if yes, what is the device return status.Surgeon: (b)(6).No other detail available.No product is available for return.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.
Event or Problem Description
It was reported a patient underwent an unknown senology surgery on an unknown date in 2022 and a reservoir was used.The product did not maintain a vacuum condition.No reported adverse patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4 expiration date, h4 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15225393
• Report Number: 2210968-2022-06599
• Device Sequence Number: 17543591
• Product Code: JOL
• UDI-Device Identifier: 10705031003309
• UDI-Public: 10705031003309
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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 Model Number: 2161
• Device Catalogue Number: 2161
• Device Lot Number: JU0535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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