inforMED
MalfunctionJOL

WAYNE

Received Jan 15, 2026 · Event occurred Oct 10, 2025

Report 24078733 · MDR key 24078733

Device

Generic name

Catheter And Tip, Suction

Manufacturer

Cook Incorporated

Model number

G56537

Catalog number

C-UTPTY-1400-WAYNE-112497-IMH

Lot number

16049354

Patient

17 YR · Male

  • Pneumothorax

Narrative

Description of Event or Problem

PATIENT IN ED; CHEST X-RAY SHOWED A VERY LARGE LEFT-SIDED PNEUMOTHORAX WITH A SUGGESTION OF MILD TENSION. THE WAYNE PNEUMOTHORAX TRAY WAS UTILIZED TO PLACE A PIGTAIL CHEST TUBE ON [REDACTED] AT 3 PM. PROCEDURE NOTE: ¿ULTRASOUND WAS USED PRIOR TO INITIATING THE PROCEDURE TO EVALUATE APPROPRIATE ANATOMY AND THE SKIN SITE WAS MARKED AT THE 3RD-4TH INTERCOSTAL SPACE ABOVE THE RIB. A NEEDLE WAS INSERTED IN THE MID AXILLARY LINE AT THE 3RD AND 4TH INTERCOSTAL SPACE OF THE FOURTH RIB, AND THIS WAS ADVANCED UNTIL AIR WAS ASPIRATED TO THE SYRINGE. SELDINGER TECHNIQUE WAS USED TO ADVANCE THE WIRE, FOLLOWED BY A SMALL 0.5 CM INCISION WITH A SCALPEL AND THEN DILATION WITH THE DILATING CATHETER. THE 12 FRENCH PIGTAIL WAS INSERTED OVERLYING THE WIRE AFTER REMOVAL OF THE NEEDLE AND DILATOR. THE PEDAL CATHETER WAS ADVANCED SUPERIORLY WITHOUT COMPLICATION AND SECURED WITH A 5-0 PROLENE SUTURE. THE CHEST TUBE INSERTED EASILY WITHOUT COMPLICATION. THERE WAS MINIMAL BLEEDING DURING THE PROCEDURE. THE CHEST TUBE WAS SECURED AND CONNECTED TO A PLEUR-EVAC DRAINAGE SYSTEM AT -20CM H2O SUCTION. PATIENT BECAME MILDLY HYPOXIC TO THE UPPER 80% AND PLACED ON 2 L SUPPLEMENTAL NASAL CANNULA OXYGEN WITH IMPROVEMENT IN THE OXYGEN TO NEAR 100%, NO OTHER COMPLICATIONS OR PROBLEMS DURING THE PROCEDURE. POST-PLACEMENT CHEST X-RAY SHOWS: PIGTAIL CHEST TUBE APPEARS TO BE APPROPRIATELY PLACED WITH RE-EXPANSION OF THE LUNGS; THERE IS A PERSISTENT SUPERIOR APICAL PNEUMOTHORAX THAT HAS SIGNIFICANTLY IMPROVED COMPARED TO THE INITIAL X-RAY READ. [REDACTED]-THE NEXT DAY AFTER CHEST TUBE WAS PLACED, X-RAY SHOWS A SMALL APICAL PNEUMOTHORAX. CHEST TUBE PLACED TO WATER SEAL AT ABOUT 2 PM. [REDACTED]-2 DAYS AFTER CHEST TUBE WAS PLACED, AT 7 AM, CHEST X-RAY SHOWS SIGNIFICANT RE-ACCUMULATION OF AIR IN PLEURAL SPACE WITH LUNG COLLAPSE ON THE LEFT. CHEST TUBE HOOKED BACK UP TO SUCTION. PROVIDER TEAM PLANNING FOR THORACOSCOPY WITH APICAL WEDGE RESECTION SURGERY ON [REDACTED]-THE NEXT DAY. [REDACTED]-3 DAYS AFTER CHEST TUBE WAS PLACED, AT 6AM AS AN RN WAS HELPING PATIENT TO BATHROOM, THE CHEST TUBE BECAME DISCONNECTED FROM THE PLEURAVAC, AND THE INTRODUCER FELL OUT OF THE CHEST TUBE PIGTAIL, ONTO THE FLOOR. (THE RETENTION OF THE INTRODUCER WAS NOT KNOWN UNTIL THIS MOMENT.) CHEST TUBE WAS CLAMPED. DISCUSSION ENSUED WITH HOSPITALIST AND SURGEON THAT INTRODUCER WAS INADVERTENTLY LEFT IN AT THE TIME OF CHEST TUBE INSERTION AND MAY HAVE RESULTED IN INADEQUATE SUCTION AND FAILURE TO RESOLVE THE PNEUMOTHORAX APPROPRIATELY. STAT X-RAY AT THIS TIME SHOWED VERY LARGE LEFT PNEUMOTHORAX. SO, THE CHEST TUBE WAS THEN RECONNECTED TO SUCTION. 5 HOURS LATER, ANOTHER X-RAY SHOWED ONLY SMALL RESIDUAL LEFT APICAL PNEUMOTHORAX. PATIENT DID NOT HAVE TO HAVE A THORACOSCOPY. CHEST TUBE REMAINED TO SUCTION ALL DAY [REDACTED]-THE DAY IT WAS PLACED. ON [REDACTED]-THE DAY AFTER, WAS PLACED TO H20 SEAL. MORNING OF [REDACTED]-2 DAYS AFTER PLACEMENT, THERE WAS A SLIGHT REDUCTION IN THE PNEUMOTHORAX (ON X-RAY) FROM 14 MM TO 11 MM. AFTERNOON OF [REDACTED]-THAT DAY, CHEST TUBE REMOVED AND PATIENT WENT HOME. TWO ISSUES OUR TEAM IDENTIFIED: 1. EVEN THOUGH THE INTRODUCER WAS LEFT IN, THE TUBE STILL WENT TO SUCTION AND THE LUNG REINFLATED. IT STILL WORKED. BUT THEN WHEN SWITCHED TO H2O SEAL, THE LUNG COLLAPSED AGAIN (PNEUMOTHORAX CAME BACK). THERE IS NO ALERT TO WARN STAFF THAT INTRODUCER IS STILL THERE. 2. IT IS VERY DIFFICULT TO RECOGNIZE THAT THE INTRODUCER WAS ACCIDENTLY LEFT IN. WHEN INTRODUCER IS LEFT IN, IT IS DARK GRAY AND APPEARS ALMOST AS IF IT BELONGS THERE, WHEN LOOKING INTO THE LEUR LOCK PIECE OF THE TUBE. OUR RECOMMENDATION IS THAT THE INTRODUCER BE COLOR-CODED WITH A BRIGHT COLOR SO THAT IT WILL BE SEEN RIGHT AWAY AND RECOGNIZED THAT IT WAS LEFT IN.