MAUDE Adverse Event Report: ETHICON INC. J-VAC RESERVOIR 300 ML; CATHETER TIP SUCTION

Model Number	2163
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: component code: g07002 - device not received.Additional information provided: did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? --> no, did the patient require revision surgery or hardware removal? --> no, 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, device property of -->none, device in possession of -->none.Additional information has been requested however not received.Attempts to obtain the product sample have been made.If further details are received at a later date a supplemental medwatch will be sent.¿ please clarify, were the eight (8) jvac reservoirs found defective over the same procedure? ¿ if no, please clarify how many patient events did the event occur on and how many reservoirs were used on each? ¿ please confirm, did all the faulty reservoirs shared the same lot number (ju0677)? ¿ if not, please clarify what is the lot number of each faulty device? ¿ please provide the source or name of person providing answers to follow-up questions to sales rep.Note: events reported on: mw# 2210968-2023-03266, mw# 2210968-2023-03267, mw# 2210968-2023-03268, mw# 2210968-2023-03270, mw# 2210968-2023-03271, mw# 2210968-2023-03272, mw# 2210968-2023-03273.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.Record with problem in the vacuum operation, the internal spring does not work.I identify a spring that broke when the patient's debt was discarded.No reported patient consequences.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.Note: events reported on: mw# 2210968-2023-03266, mw# 2210968-2023-03267, mw# 2210968-2023-03268, mw# 2210968-2023-03270, mw# 2210968-2023-03271, mw# 2210968-2023-03272, mw# 2210968-2023-03273.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 300 ML
• Common Device Name: CATHETER 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: 16865208
• Report Number: 2210968-2023-03269
• Device Sequence Number: 12127634
• Product Code: JOL
• UDI-Device Identifier: 10705031003323
• UDI-Public: 10705031003323
• 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): 05/12/2023

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: 2163
• Device Catalogue Number: 2163
• Device Lot Number: JU0677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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