MAUDE Adverse Event Report: ETHICON INC. J-VAC*RESEVOIR 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	12/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: did the patient experience a post-op device malfunction? unknown, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? unknown, patient status/outcome / consequences.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Additional information has been requested, however not received to date.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent.Please clarify how did the reservoir fail to perform to spec? when was the issue noticed (intra-op or post-op during recovery)? how was the case resolved? was another reservoir used to correct the situation? were there any patient consequences? if so, was there any associated medical or surgical intervention? device return status.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.After procedure, the reservoir failed to perform to specification.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4, h4, h6 component code: g07002 product not returned.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.

• 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
• MDR Report Key: 13588966
• Report Number: 2210968-2022-01275
• Device Sequence Number: 11744197
• Product Code: JOL
• UDI-Device Identifier: 10705031003323
• UDI-Public: 10705031003323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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 Expiration Date: 07/31/2025
• Device Model Number: 2163
• Device Catalogue Number: 2163
• Device Lot Number: JU0196
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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