Wayne G56533Recalls & reported problems
Cook Incorporated · Wayne Pneumothorax Set · Class 2
Quick summary
This Cook Wayne Pneumothorax Set is a suction catheter and tip used to drain air and fluid from the chest. The 27 reports mostly describe problems found before or during use: contaminated or unsterile packaging with hair or other foreign material found inside the box, plus leaking and separation of parts from the chest drain valve. Two injuries and no deaths were reported, and most mentions involved no patient contact at all. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00827002565333), received between Jul 21, 2017 and Dec 13, 2023 — classified as 2 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (14 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.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping14
- Device Contamination with Chemical or Other Material4
- Contamination /Decontamination Problem3
- Delivered as Unsterile Product3
- Leak/Splash3
- Air Leak1
- Fracture1
- Gas/Air Leak1
Patient problems
- No Patient Involvement20
- No Clinical Signs, Symptoms or Conditions6
- Dyspnea1
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Pneumothorax1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE COOK CHEST DRAIN VALVE FROM A WAYNE PNEUMOTHORAX SET LEAKED. THE DEVICE WAS REQUIRED FOR A RIGHT CHEST DRAINAGE PROCEDURE. AFTER THE DEVICE WAS PLACED, THE COOK CHEST DRAIN VALVE LEAKED PLEURAL FLUID AT THE JUNCTION OF THE BLUE PIECE AND THE TRANSPARENT PIECE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18323353 ↗MalfunctionApr 24, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 16794681 ↗InjuryFeb 14, 2023Leak/Splash; Separation Problem; Leak/Splash; Separation Problem
IT WAS REPORTED THAT A CHEST DRAIN VALVE IN WAYNE PNEUMOTHORAX SET LEAKED. THE DEVICE WAS PLACED BY MICRO-PUNCTURE IN THE PLEURAL CAVITY FOR DRAINAGE OF AIR AND FLUID AND WAS SECURELY CONNECTED TO A COLLECTION BAG. TWO DAYS LATER LEAKAGE WAS DISCOVERED AT THE DISTAL END OF THE CHEST DRAIN VALVE. IT WAS NOTED THAT NO FORCE HAD BEEN EXERTED ON THE CATHETER. FURTHER COMMUNICATION WITH THE CUSTOMER INDICATED THAT THE PHYSICIAN WAS CONCERNED ABOUT CONTAMINATION; THEREFORE, THE ENTIRE CHEST DRAIN SYSTEM WAS REMOVED AND REPLACED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16375174 ↗MalfunctionOct 29, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12719620 ↗MalfunctionAug 27, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A HAIR WAS OBSERVED INSIDE THE PRIMARY PACKAGING OF A WAYNE PNEUMOTHORAX SET. THIS WAS NOTED DURING INITIAL INSPECTION AND THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12378726 ↗MalfunctionOct 15, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10685636 ↗MalfunctionOct 13, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10671323 ↗MalfunctionSep 3, 2020Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING INSPECTION, A DISTRIBUTOR DISCOVERED FOREIGN MATTER INSIDE THE PRIMARY PACKAGING OF A WAYNE PNEUMOTHORAX SET. THE FOREIGN MATTER WAS REPORTED TO BE A "LINE", POSSIBLY A HAIR. NO PATIENT CONTACT WAS MADE.
Patient problems: No Patient Involvement
MAUDE report 10492086 ↗MalfunctionAug 20, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED BY THE CUSTOMER THAT DURING SHIPPING INSPECTION OF THE PRODUCT, PARTICLES WERE FOUND INSIDE THE DEVICE PRIMARY PACKAGING. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 10431136 ↗MalfunctionJul 1, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING INSPECTION, A HAIR WAS OBSERVED INSIDE THE PRIMARY PACKAGING OF A WAYNE PNEUMOTHORAX SET. NO PATIENT CONTACT WAS MADE.
Patient problems: No Patient Involvement
MAUDE report 10221032 ↗MalfunctionJul 1, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING INSPECTION, A FOREIGN PARTICLE WAS NOTICED IN THE PRIMARY PACKAGING OF A WAYNE PNEUMOTHORAX SET. NO PATIENT CONTACT WAS MADE.
Patient problems: No Patient Involvement
MAUDE report 10220927 ↗MalfunctionJun 2, 2020Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10111631 ↗MalfunctionJan 28, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 9636391 ↗MalfunctionDec 10, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 9444681 ↗MalfunctionNov 5, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 9281601 ↗MalfunctionOct 18, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING THE INSPECTION OF A COOK WAYNE PNEUMOTHORAX SET, AN UNIDENTIFIED PARTICLE WAS OBSERVED INSIDE OF THE PRIMARY PACKAGING OF THE PRODUCT. NO PATIENT CONTACT WAS MADE.
Patient problems: No Patient Involvement
MAUDE report 9208951 ↗MalfunctionSep 10, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8983059 ↗MalfunctionJul 8, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8768456 ↗MalfunctionFeb 1, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 8296744 ↗MalfunctionFeb 1, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 8296518 ↗MalfunctionJan 15, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED FOREIGN MATTER, BLACK HAIR, WAS FOUND DURING INCOMING INSPECTION IN A SEALED WAYNE PNEUMOTHORAX SET. THE REPORTED PRODUCT DID NOT MAKE PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8248383 ↗MalfunctionOct 15, 2018Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak
IT WAS REPORTED A WAYNE PNEUMOTHORAX SET WAS USED DURING A PROCEDURE AND LEAKAGE WAS OBSERVED IN THE HEIMLICH VALVE. THE VALVE WAS REMOVED AND REPLACED WITH A LIKE DEVICE FOR ANOTHER KIT BY THE THORACIC SURGEON DURING THE SAME PROCEDURE. TO DATE, ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED BY THE CUSTOMER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 7965078 ↗MalfunctionSep 24, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED DURING INCOMING INSPECTION FOREIGN MATTER, BLACK HAIR, WAS FOUND INSIDE THE PRIMARY PACKAGING OF A SEALED WAYNE PNEUMOTHORAX SET. AS REPORTED, THIS DEVICE ISSUE WAS DISCOVERED DURING INSPECTION; THEREFORE, IT DID NOT MAKE CONTACT WITH THE USER OR PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7901430 ↗MalfunctionMar 6, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A PRE-USE INSPECTION OF THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER, AN UNIDENTIFIED PARTICLE WAS DISCOVERED WITHIN THE PRIMARY PACKAGE OF THE DEVICE. THE DEVICE WAS NOT USED ON A PATIENT; ACCORDINGLY, NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT ISSUE. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.
Patient problems: No Patient Involvement
MAUDE report 7318771 ↗InjuryNov 15, 2017Air Leak; Fracture; Air Leak; Fracture
THE CUSTOMER REPORTED THAT THE WAYNE PNEUMOTHORAX CHEST TUBE CRACKED. THE PATIENT WAS PREVIOUSLY ADMITTED FOR LUNG SURGERY, AND DEVELOPED A COLLAPSED LUNG AFTER THE SURGERY. THE PATIENT WAS SENT HOME ON (B)(6) 2017, WHICH WAS 12 DAYS POST OPERATIVELY, WITH A CHEST TUBE IN PLACE FOR THE CONTINUED CARE OF A SMALL AIR LEAK. TWO DAYS FOLLOWING, THE PATIENT REPORTED SEVERE DYSPNEA, AND WHEN SEEN IN THE SURGEON'S OFFICE, THE FRACTURE WAS OBSERVED IN THE CHEST TUBE APPROXIMATELY 2 CM DISTAL TO THE SUTURE LINE. THE FRACTURE WAS PATCHED, AND THE PATIENT'S LUNG WAS MANUALLY RE-EXPANDED. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL, AND ANOTHER CHEST TUBE WAS PLACED. THE PATIENT REPORTEDLY REMAINS IN THE HOSPITAL WITH A SLOWLY RESOLVING PNEUMOTHORAX. ADDITIONAL INFORMATION WAS LATER RECEIVED IN RESPONSE TO A REQUEST FOR ADDITIONAL INFORMATION WHICH WAS SENT TO THE CUSTOMER. THE DEVICE WAS PLACED N THE POST ANESTHESIA CARE UNIT, AND THE FLUID WHICH WAS BEING DRAINED WAS FLUID FROM THE PNEUMOTHORAX. THE DEVICE WAS IN PLACE FOR 7 DAYS, AND THE DEVICE WAS REPORTEDLY PATCHED USING TAPE, WHICH WAS WRAPPED AROUND THE FRACTURE TO STOP THE LEAKING OF AIR. THE PATIENT HAS ALSO REPORTEDLY BEEN DISCHARGED
Patient problems: Dyspnea; No Code Available; Pneumothorax
MAUDE report 7036189 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.