MAUDE Adverse Event Report: ETHICON INC. J-VAC*RESV. 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	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested and the following was obtained.No product will be returned as it was discarded.If further details are received at a later date a supplemental medwatch will be sent.Did the reservoir function properly upon first activation? if yes, how long after the first activation happened did the issue occurred? answer: it was not functioning well when start.Was another reservoir used to correct the situation? answer: no, other product was used.Can you please confirm, was the reservoir stained with blood while in use? answer: according to hcp, the reservoir was blood-stained during their attempt to do vacuum.
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date in 2021 and a reservoir was used.During the procedure, there was a vacuum problem during suction with reservoir and suction was unsuccessful.Item was discarded as it is blood stained.Another reservoir was used.Procedure was completed.No adverse patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/20/2021.Additional information: h4.Corrected data: d3.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 product complaint # (b)(4).Date sent to the fda: 4/20/2021.Corrected data: d3.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 AND TIP SUCTION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11334382
• Report Number: 2210968-2021-01461
• Device Sequence Number: 19047227
• Product Code: JOL
• UDI-Device Identifier: 10705031003309
• UDI-Public: 10705031003309
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 11/30/2020
• Device Model Number: 2161
• Device Catalogue Number: 2161
• Device Lot Number: JT8327
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/20/2021
• Patient Sequence Number: 1