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	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent a mastectomy on (b)(6) 2021 and a reservoir was used.During surgery, when the reservoir was used it did not compress.When they squeezed the white plates together, the central window did not click into place, unable to create a vacuum.They have used for this patient another reservoir to monitor the this one to make sure that it is not faulty and did not work properly.Surgery delayed about 5 - 10 minutes, action taken when event occurred, took a third one that worked.Procedure successfully completed.No adverse patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: were fragments generated? no, if yes, were they removed easily without additional intervention? unknown, 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, additional information has been requested however not received.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? did the reservoir come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? was air leakage detected? by the description of the issues appears it was used the names "reservoir" and "drains" interchangeably, please clarify which product did not compress and was unable to create a vacuum: device return status: note: events reported on mw# 2210968-2021-11531.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).Additional information: d4, h4, h6 component code: g07002 product not returned.Additional information has been requested and received.Attempts have been made to obtain the product, not received to date.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? ju0139 for x2 2163 j-vac reservoir did the reservoir come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? no.Was air leakage detected? no air leakage detected.By the description of the issues appears it was used the names "reservoir" and "drains" interchangeably, please clarify which product did not compress and was unable to create a vacuum: the reservoir did not compress and was unable to create a vacuum.There was 2 reservoirs that malfunctioned.The third opened reservoir worked perfectly.Device return status: not available, been discarded by the hospital.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: 12821268
• Report Number: 2210968-2021-11532
• Device Sequence Number: 14678872
• Product Code: JOL
• UDI-Device Identifier: 10705031003323
• UDI-Public: 10705031003323
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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: 03/31/2025
• Device Model Number: 2163
• Device Catalogue Number: 2163
• Device Lot Number: JU0139
• 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: 10/26/2021
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown