Wayne G11182Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00827002111820), received between Jul 27, 2017 and Aug 25, 2022 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 reports).

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2022Break; Break

  IT WAS REPORTED A 57 YEAR-OLD MALE PATIENT REQUIRED REPLACEMENT OF THE CATHETER FROM A WAYNE PNEUMOTHORAX SET. SOMETIME AFTER INITIAL PLACEMENT, THE CATHETER WAS FOUND TO BE BROKEN AFTER THE PATIENT WAS TRANSFERRED TO THE WARD. THIS RESULTED IN A PNEUMOTHORAX FOR THE PATIENT. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE DEVICE AND PLACE ANOTHER SET OF SAME DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Pneumothorax

  MAUDE report 15296645 ↗
• MalfunctionDec 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916792 ↗
• MalfunctionNov 1, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728111 ↗
• MalfunctionSep 20, 2021Unraveled Material; Unraveled Material

  IN ADDITIONAL INFORMATION RECEIVED ON 15NOV2021, IT WAS REPORTED THAT THE OBTURATOR WAS USED TO INSERT THE CATHETER. THE OBTURATOR AND WIRE GUIDE WERE REMOVED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12501004 ↗
• MalfunctionSep 20, 2021Unraveled Material; Unraveled Material

  IN ADDITIONAL INFORMATION RECEIVED ON 15NOV2021, IT WAS REPORTED THAT THE OBTURATOR WAS USED TO INSERT THE CATHETER. THE OBTURATOR AND WIRE GUIDE WERE REMOVED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12500585 ↗
• MalfunctionMay 25, 2021Connection Problem; Connection Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11879820 ↗
• MalfunctionNov 5, 2020Material Separation; Fitting Problem; Material Separation; Fitting Problem

  IT WAS REPORTED THAT THE CATHETER OF A WAYNE PNEUMOTHORAX SET SEPARATED AT THE HUB. THE DEVICE WAS BEING INSERTED TO DRAIN THE PATIENT'S LEFT PLEURAL EFFUSION. FOLLOWING IMPLANTATION, AS THE PHYSICIAN MOVED THE "DRAINAGE BOTTLE", THE CATHETER SEPARATED AT THE HUB. CONSEQUENTLY, THE PHYSICIAN REMOVED THE DEVICE AND INSERTED A NEW DEVICE IMMEDIATELY. THE DEVICE WAS SECURED TO THE PATIENT AS PER IFU RECOMMENDATIONS AND HAD BEEN CONNECTED TO A DRAINAGE SYSTEM. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10793511 ↗
• InjuryJul 22, 2020Material Separation; Material Separation

  IN ADDITIONAL INFORMATION RECEIVED ON 21JUL2020, IT WAS REPORTED THAT THE OBTURATOR WAS NOT REMOVED FROM THE DEVICE AND THE CATHETER WAS SECURED TO THE PATIENT BY PIGTAIL. THE CATHETER WAS FOUND TO BE SEPARATED AT THE HUB. A NEW C-UTPT-1400-WAYNE-112497 WAS PLACED.

  Patient problems: No Code Available

  MAUDE report 10310249 ↗
• MalfunctionNov 26, 2019Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9376889 ↗
• MalfunctionSep 18, 2019Separation Problem; Separation Problem

  ON 15OCT2019, A REVISED FORMAL COMPLAINT LETTER FROM THE COMPLAINANT WAS RECEIVED THAT PROVIDED MORE INFORMATION ABOUT THE IMPLANT AND EVENT DATES. A WAYNE PNEUMOTHORAX SET WAS IMPLANTED INTO A PATIENT ON (B)(6) 2019. THE SEPARATION OF THE DEVICE HAPPENED ON 27AUG2019. ON 07NOV2019, IT WAS REPORTED BY A DOCTOR WHO WORKED AT THE COMPLAINANT FACILITY AND WAS AWARE OF THE SEPARATION ISSUES WITH THE COMPLAINT PRODUCT THAT THE DRAINAGE TUBES OF THE IN-SITU CHEST TUBES WERE ATTACHED TO THE HOSPITAL BED AT THE TIME OF THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9083527 ↗
• InjuryAug 5, 2019Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2019, AT THE (B)(6) HOSPITAL, A WAYNE PNEUMOTHORAX SET EXTERNAL DRAIN CONNECTION BROKE APART FROM THE DEVICE'S THREE-WAY ATTACHMENT AFTER A PLEURAL CATHETER INSERTION. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE WHO HAD A PRE-EXISTING RIGHT HEPATIC HYDROTHORAX. THE EXTERNAL CONNECTION POINT BETWEEN THE DRAIN AND THE THREE-WAY ATTACHMENT LOCATED ON THE CATHETER SEPARATED. CONDITIONS AS TO WHICH THIS EVENT OCCURRED WERE REPORTED AS UNCERTAIN. THE PHYSICIAN WAS REQUIRED TO ESTABLISH A CONNECTION IN PLACE AND DID SO SUCCESSFULLY, ALLOWING THE DRAIN TO FUNCTION AS INTENDED. THE INTERNAL PORTION OF THE CATHETER REMAINED IN-TACT WITHOUT ISSUE. THE DRAIN WAS REMOVED ON (B)(6) 2019, "LIKELY DUE TO THE FACT THAT THE EFFUSION HAD LARGELY RESOLVED AT THAT POINT, AND SINCE THERE WAS SOME CONCERN AS TO THE INTEGRITY OF THE DRAIN AT THAT POINT, THE DECISION WAS MADE TO REMOVE THE DRAIN," AS STATED BY THE PHYSICIAN. ANOTHER DEVICE WAS PLACED ON (B)(6) 2019 DUE TO RE-ACCUMULATION OF THE PLEURAL EFFUSION. REGARDING THE RE-INSERTION, THE PHYSICIAN ALSO STATED THAT, "THERE IS AN ARGUMENT TO BE MADE THAT THE REINSERTION IS NOT DIRECTLY A RESULT OF THE BREAKAGE IN THE INITIAL

  Patient problems: No Code Available

  MAUDE report 8861786 ↗
• MalfunctionAug 2, 2019Material Separation; Material Separation

  ON 07NOV2019, IT WAS REPORTED BY A DOCTOR WHO WORKED AT THE COMPLAINANT FACILITY AND WAS AWARE OF THE SEPARATION ISSUES WITH THE COMPLAINT PRODUCT, THAT THE DRAINAGE TUBING OF THE IN-SITU CHEST TUBES WERE ATTACHED TO THE HOSPITAL BED AT THE TIME OF THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8856214 ↗
• MalfunctionMay 14, 2019Material Separation; Material Separation

  IT WAS REPORTED IN INFORMATION RECEIVED ON (B)(6) 2019 THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL PROCEDURES WERE REQUIRED, AS THE PHYSICIAN USED A NEW DEVICE TO COMPLETE THE PROCEDURE. THE SEPARATION WAS DISCOVERED PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8609376 ↗
• InjuryMay 1, 2019Material Separation; Material Separation

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT.

  Patient problems: Pneumothorax

  MAUDE report 8568948 ↗
• InjuryApr 10, 2019Material Separation; Material Separation

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Pneumothorax

  MAUDE report 8501312 ↗
• MalfunctionFeb 11, 2019Material Separation; Material Separation

  NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 8325153 ↗
• MalfunctionFeb 7, 2019Disconnection; Disconnection

  IT WAS REPORTED IN ADDITIONAL INFORMATION RECEIVED ON 11FEB2019 THAT THE PATIENT WENT TO THE ENDOSCOPY CENTRE FOR A RIGHT PERCUTANEOUS DRAINAGE CATHETER INSERTION ON (B)(6) 2019. THE PROCEDURE BEGAN AT 1630 AND WAS COMPLETED SUCCESSFULLY BY 1655. ONLY ACCESSORIES IN THE WAYNE PNEUMOTHORAX SET WERE USED DURING THE PROCEDURE. IT WAS NOTED IN THE WARD ON (B)(6) 2019 THAT THE TUBING CONNECTION NEAR THE 3-WAY STOPPER HAD DISCONNECTED. IT WAS REPORTED ON (B)(6) 2019 THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8317013 ↗
• InjuryApr 13, 2018Fitting Problem; Fitting Problem

  CUSTOMER REPORTED THAT DURING A THORACENTESIS UNDER DIRECT ULTRASOUND GUIDANCE TO DRAIN AN INFECTED FOCI PROCEDURE, A WAYNE PNEUMOTHORAX SET CATHETER WAS DEPLOYED ON A (B)(6)-YEAR OLD MALE PATIENT ON (B)(6) 2018. A CRACKED STOPCOCK WAS DISCOVERED ON (B)(6) 2018, AND AN APPOINTMENT WAS SCHEDULED TO REPLACE THE STOPCOCK WITHOUT REMOVING THE ENTIRE WAYNE PNEUMOTHORAX SET. THIS PROCEDURE WAS UNSUCCESSFUL AND THE DEVICE WAS REPLACED WITH A SECOND DEVICE ON (B)(6) 2018. NO ADDITIONAL PROCEDURES HAVE BEEN REPORTED TO DATE.

  Patient problems: No Code Available

  MAUDE report 7428636 ↗
• MalfunctionMar 27, 2018Crack; Defective Component; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THREE WAYNE PNEUMOTHORAX SETS WERE DEFECTIVE. THE FIRST GUIDEWIRE DIDN¿T ADVANCE SMOOTHLY AND WAS FOUND TO HAVE AN ABNORMAL CURVE AND TWIST AT THE TIP. THE PHYSICIAN USED A SECOND WIRE WITH THE DILATOR FROM THE FIRST KIT, WHICH HAD A PROBLEM WITH THE TIP, MAKING IT UNUSABLE. THE DILATOR FROM THE SECOND KIT HAD THE SAME PROBLEM, SO THE DILATOR FROM A THIRD KIT WAS USED, BUT THIS WAS REPORTEDLY CRACKED. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED, BUT THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7372959 ↗
• MalfunctionOct 7, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, WHEN HANDLING THE CATHETER CONTAINED IN THE WAYNE PNEUMOTHORAX SET, THE JOINTS CREATED BETWEEN THE DIFFERENT COMPONENTS WERE LOOSENED TOO EASILY. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN. THE PRODUCT IS REPORTEDLY NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6926282 ↗
• MalfunctionOct 7, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, WHEN HANDLING THE CATHETER CONTAINED IN THE WAYNE PNEUMOTHORAX SET, THE JOINTS CREATED BETWEEN THE DIFFERENT COMPONENTS WERE LOOSENED TOO EASILY. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN. THE PRODUCT IS REPORTEDLY NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6926272 ↗
• MalfunctionSep 19, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, WHEN HANDLING THE CATHETER CONTAINED IN THE WAYNE PNEUMOTHORAX SET, THE JOINTS CREATED BETWEEN THE DIFFERENT COMPONENTS WERE LOOSENED TOO EASILY. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN. THE PRODUCT IS REPORTEDLY NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6877252 ↗
• MalfunctionJul 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT RECEIVED A WAYNE PNEUMOTHORAX CATHETER ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6747820 ↗