Skater™ All-Purpose and Nephrostomy Set 756608025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886333217786), received between Feb 28, 2023 and Apr 26, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  COMPLICATIONS OF PULLING A PLEURAL DRAIN. THREE PATIENTS WHO RECEIVED A PLEURAL DRAIN. 3 OF 3. (B)(6) MUST FLUSH THE DRAIN DUE TO BLOOD IN THE HOSE. WE GET ASSISTANCE FROM (B)(4). IT IS NOT POSSIBLE TO FLUSH, SO IT IS DECIDED BY (B)(6) THAT WE SHOULD DRAIN THE DRAIN. (B)(4), WHICH IS USED TO PULLING DRAINS, IS INVOLVED. WE CUT THE ONE BLACK THIN THREAD. THE DRAIN HOSE ITSELF IS ALMOST OUT BUT THE THREAD IS STUCK. CALLING THE NARCOTICS EMERGENCY, WHO ALSO CAN'T GET THE BLACK THREADS OUT. WE CALL SURGEONS WHO ARE ALSO UNSUCCESSFUL. THE DRAIN HOSE IS PULLED OUT. THE SURGEON INFORMS (B)(6) THAT NOW I TAKE A LITTLE. THEN THE THREAD COMES OUT. JUDGES THAT ABOUT 8 CM WAS LEFT.

  Patient problems: Insufficient Information

  MAUDE report 19189427 ↗
• InjuryApr 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  COMPLICATIONS OF PULLING A PLEURAL DRAIN. THREE PATIENTS WHO RECEIVED A PLEURAL DRAIN 2 OF 3. (B)(6) WHERE THE PLEURAL DRAIN WAS PULLED IN THE EVENING. IT WAS REMOVED ACCORDING TO THE PM BUT COULD NOT BE REMOVED. THE BLACK THIN WIRES WERE STUCK. LEFT WITH A DRAIN HALFWAY OUT. ANESTHESIOLOGISTS OR BACK-UP MEDICINE WERE BUSY. (B)(4) SAID WE SHOULD CUT ONE OF TWO THIN BLACK WIRES. IT WAS STILL IMPOSSIBLE TO PULL OUT. IN THE END WE CALL RTG WHO CAN HELP US. ACCORDING TO THEIR ANSWER, THEY HAD TO CUT OPEN THE DRAIN PIPES THEMSELVES SO THAT THE THREADS BECAME VISIBLE AND SOMEHOW PRY/PULL SO THAT THE THREADS RELEASE. THE DRAIN ITSELF IS NO PROBLEM TO PULL OUT.

  Patient problems: Insufficient Information

  MAUDE report 19189335 ↗
• InjuryApr 26, 2024Defective Device; Defective Device

  COMPLICATIONS OF PULLING A PLEURAL DRAIN. THREE PATIENTS WHO RECEIVED A PLEURAL DRAIN. (B)(6) WHERE THE PLEURAL DRAIN WAS DRAWN ON EM. CONTROL X-RAY SHOWS SMALL PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 19189304 ↗
• MalfunctionSep 22, 2023Air/Gas in Device; Air/Gas in Device

  THE COME ACROSS A PROBLEM WITH THE PLEURAL DRAIN INSERT, 6 AND 8 F, NAMELY WHEN ASPIRATION ONLY AIR OR A LARGE AMOUNT OF AIR COMES OUT AND ANY PNEUMOTHORAX COULD NOT BE CONFIRMED DURING THE CHECK WITH CT. THERE HAS ALSO BEEN AIR AT THE COUPLING WITH A THREE-WAY VALVE AND THE COLLECTION BAG. SO EVERYTHING THAT THE CUSTOMER HAVE DONE BEFORE ACCORDING TO OUR ROUTINES. SO SUSPECTED AIR INTAKE FROM THE THREAD OPENING, CUSTOMER ASSUME. IT HAS BEEN NOTED DURING THE LAST 2 WEEKS. VERY UNPLEASANT. HAS ANYTHING CHANGED IN THE MAKE?

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

  MAUDE report 17797405 ↗
• InjuryFeb 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT COMES FOR A CHECK-UP DUE TO WET DRESSINGS AROUND THE NEPHROSTOMY. IT TURNS OUT THAT THE LEAK IS FROM THE CATHETER'S WHITE CONNECTOR ITSELF AND NOT BETWEEN THE CATHETER AND THE COLLECTION THE HOSE. DECISION ON CHANGE. GIDEWIRE ARE INSERTED INTO THE RENAL PELVIS. WHEN THE CATHETER IS EXTRACTED, BLEEDING FROM THE CATHETER HOLE IS OBTAINED. THE CATHETER WAS CHANGED TO A 10 FRENCH CATHETER MINIPIGTAIL, THUS A SIZE LARGER THAN BEFORE TO POSSIBLY TAMPONADE THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16457112 ↗