SKATER™ All Purpose and Nephrostomy Drainage Set 756608035Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886333225132), received between Mar 7, 2023 and Aug 22, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Break; Break

  EVENT 2: PROBLEM PULLING PIGTAIL DRAIN. WHEN PULLING THE PLEURAL DRAIN, THE GREEN/BLUE DRAINAGE TUBE ITSELF COMES OUT WITHOUT PROBLEMS, BUT A NEW THREAD (WHICH IS INSIDE THE GREEN/BLUE TUBE) REMAINS INSIDE THE SKIN AND CANNOT BE PULLED OUT. STICKS ROCK HARD. THIS PROVIDED THAT THE KNOTS WERE PROPERLY DISSOLVED. THE PATIENT HAS ONLY HAD HIS DRAIN FOR TWO DAYS. ACTIONS TAKEN TRIED TO CUT ONE END OF THE WIRE, BUT IT STILL WON'T PULL OUT. ENLISTS THE HELP OF DR. WILTZ COMING TO THE PATIENT. TOGETHER WE TRY TO PULL IT OUT AND THEN CUT THE OTHER END OF THE WIRE TO DETACH THE DRAIN HOSE ITSELF. HOLDS THE THREAD WITH TWEEZERS. HOWEVER, THERE IS SUCH PRESSURE IN THE NYLON THREAD THAT IT IS TORN AWAY FROM THE TWEEZERS AND SUCKED INTO THE SKIN AGAIN. THE PATIENT THUS STILL HAS SOME NYLON THREAD INSIDE THE BODY. THE PATIENT IS INFORMED AND IT IS DOCUMENTED BY THE DOCTOR IN THE MEDICAL RECORD.

  Patient problems: Foreign Body In Patient

  MAUDE report 17597200 ↗
• MalfunctionAug 22, 2023Break; Break

  EVENT 1: PROBLEM PULLING PIGTAIL DRAIN: I WOULD WIND UP THE PATIENT'S ASCITES DRAIN THAT HE RECEIVED ON AUGUST 2ND. I DISSOLVE THE KNOTS ON THE DRAIN ACCORDING TO ROUTINE. THIS IS EASY. WHEN I THEN HAVE TO PULL OUT THE DRAIN, IT TAKES A BIT TO START PULLING, IT'S TOUGHER THAN USUAL AND THE GREEN/BLUE HOSE DOESN'T SLIDE OUT AS WELL. THEN WHEN I HAVE TO PULL OUT THE LAST PIECE, IT STOPS. I PULL A LITTLE MORE ON THE DRAIN AND THE WHOLE DRAIN COMES OUT, BUT THEN I SEE THAT THE NYLON THREAD IS STUCK INSIDE THE PATIENT. I SEE THAT THE KNOT IS DEVELOPED AS IT USUALLY IS, BUT THAT THE NYLON THREAD TIGHTENS PROPERLY BETWEEN THE DRAINAGE TUBE AND INSIDE THE ABDOMEN. I THEN CALL THE DOCTOR IN CHARGE TO LOOK AT THIS. TOGETHER WITH ME, WE PUT A PEANG ON EACH THREAD AND TAKE SCISSORS TO CUT THE THREAD THAT SITS AT THE BOTTOM OF THESE. THE DOCTOR CAN THEN PULL THE THREAD OUT OF THE PATIENT'S ABDOMEN. THE WIRE THAT WAS INSIDE THE PATIENT MEASURED ABOUT 20CM. ACTIONS TAKEN TRIED TO CUT ONE END OF THE WIRE, BUT IT STILL WON'T PULL OUT. ENLISTS THE HELP OF DR. (B)(6) COMING TO THE PATIENT. TOGETHER WE TRY TO PULL IT OUT AND THEN CUT THE OTHER END OF THE WIRE TO DETACH THE DRAIN HOSE ITSELF. HOLDS THE

  Patient problems: Foreign Body In Patient

  MAUDE report 17597167 ↗
• MalfunctionMay 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER: "FLUID LEAKS AT THE LOCKING THREAD, WHICH LEADS TO AN UNNECESSARY CHANGE OF THE DRAIN IMMEDIATELY AFTER DRAIN INSERTION. SOMETIMES WE NOTICE THAT IT IS LEAKING BEFORE WE SEND THE PATIENT BACK HOME. OR THAT PATIENTS NOTICE THAT THE BED IS WET WHEN THEY GET HOME/THE DEPARTMENT, THEN COME BACK TO CHANGE THE DRAIN. THE LEAK COMES FROM THE SIDE HOLE AND NOT IN THE CONNECTION BETWEEN THE CATHETER AND CONNECTING TUBE (DRAINAGE BAG)".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872640 ↗
• MalfunctionMar 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER EXPERIENCED LEAKAGE FROM CATHETER, FROM THE HOLE WERE THE STRING COMES OUT DURING THE PROCEDURE. THE CUSTOMER WAS FORCED TO CHANGE THE CATHETER OVER THE WIRE. THE CUSTOMER HAS USED SKATER FOR A LONG TIME AND HAS NOT EXPERIENCED THIS BEFORE. THEY EXPERIENCED 4 OCCASIONS WITH TROUBLE OF LEAKAGE. THE CUSTOMER DECIDED TO REMOVE REST OF PRODUCTS FROM THE BATCH.

  Patient problems: Insufficient Information

  MAUDE report 16496280 ↗