|
Catalog Number 2227 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/28/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Note: events reported on mw# 2210968-2024-04692.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 Description
|
It was reported a patient underwent an anterior cervical fusion/acf on (b)(6) 2024 and a drain was used.During the procedure, the reservoir swelled immediately after suction.It was unknown the reason even though the user confirmed the wound, the tube and connection part.There were no adverse consequences to the patient.
|
|
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.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).H3 evaluation: product sample received for analysis.Complaint sample review : one complaint sample of drain with attached adapter was received for evaluation, product was inspected visually below are detailed observation: 1.There was a thread binded nearby the black dot.2.While viewing nearby binding area under magnification, a sharp cut was visible.Documents review : during investigation of complaint, batch review of in-process and final packaging inspections, as well as the manufacturing process is performed, these products are reported to be manufactured, inspected, and packaged in conformance with customer's specifications and have been found to be acceptable within all parameters.No discrepancy as per the reported defect is observed.Retention sample review : no negative observation was found.It is suspected that, cut mark section of the drain might have came in contact with some sharp tool used prior / during surgery, and lead to the defect generation.Which indicates that external factors like mishandling or improper usage at user end could not be ruled out.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.
|
|
Search Alerts/Recalls
|
|
|