Wayne G09922Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002099227), received between Nov 10, 2016 and Dec 13, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE SHAFT OF A WAYNE PNEUMOTHORAX CATHETER SEPARATED WHEN A PATIENT EXTRACTED IT FROM THEIR BODY. THE PATIENT BECAME "EXCITED" AND EXTRACTED THE CATHETER FROM THEMSELVES. THE PART OF THE DEVICE OUTSIDE THE BODY WAS TORN OFF WHEN THE PATIENT EXTRACTED IT. IT WAS REPORTED THAT NOTHING WAS CONNECTED TO THE CATHETER AT THE TIME OF THE EVENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT REQUIRED REPLACEMENT OF THE CATHETER. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 9467091 ↗
• MalfunctionNov 10, 2016Leak/Splash; Gas/Air Leak; No Apparent Adverse Event; Leak/Splash; Gas/Air Leak; No Apparent Adverse Event

  NO ADDITIONAL DETAILS REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 6094130 ↗