Fuhrman G55715Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002557154), received between Apr 5, 2017 and Dec 28, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE IN A FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET SEPARATED. THE DEVICE WAS REQUIRED BY A (B)(6) MALE FOR PLEURAL DRAINAGE. DURING THE PROCEDURE, AFTER PLACING THE CATHETER, THE USER PULLED ON THE WIRE GUIDE AND DISCOVERED IT WAS "SPLIT." THE USER THEN OBTAINED ANOTHER DEVICE OF THE SAME LOT AND AGAIN ATTEMPTED TO PLACE THE CATHETER. DURING REMOVAL OF THE REPLACEMENT WIRE GUIDE, THE WIRE AGAIN BROKE. IN THIS OCCURRENCE, A PORTION OF THE WIRE REMAINED IN THE PATIENT. SUBSEQUENTLY, THE USER WAS ABLE TO REMOVE THE REMNANT OF THE WIRE "BY PULLING THE DRAINAGE." THE PROCEDURE WAS COMPLETED BY OBTAINING A THIRD DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. TWO PHOTOS PROVIDED BY THE CUSTOMER DEPICT AN UNRAVELED WIRE GUIDE AND A SEPARATED WIRE GUIDE. THIS REPORT WILL FOCUS ON THE SECOND WIRE GUIDE SEPARATION. THE BROKEN WIRE GUIDE HAS BEEN REPORTED UNDER PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101499 ↗
• MalfunctionDec 28, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE IN A FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET UNRAVELED. THE DEVICE WAS REQUIRED BY A (B)(6) MALE FOR PLEURAL DRAINAGE. DURING THE PROCEDURE, AFTER PLACING THE CATHETER, THE USER PULLED ON THE WIRE GUIDE AND DISCOVERED IT WAS "SPLIT." THE USER THEN OBTAINED ANOTHER DEVICE OF THE SAME LOT AND AGAIN ATTEMPTED TO PLACE THE CATHETER. DURING REMOVAL OF THE REPLACEMENT WIRE GUIDE, THE WIRE AGAIN BROKE. IN THIS OCCURRENCE, A PORTION OF THE WIRE REMAINED IN THE PATIENT. SUBSEQUENTLY, THE USER WAS ABLE TO REMOVE THE REMNANT OF THE WIRE "BY PULLING THE DRAINAGE." TWO PHOTOS PROVIDED BY THE CUSTOMER AGAIN DEPICTS AN UNRAVELED WIRE GUIDE AND A SEPARATED WIRE GUIDE. THE PROCEDURE WAS COMPLETED BY OBTAINING A THIRD DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. THIS REPORT WILL FOCUS ON THE FIRST BROKEN WIRE GUIDE. THE SECOND WIRE GUIDE SEPARATION HAS BEEN REPORTED UNDER PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101463 ↗
• MalfunctionAug 27, 2019Flaked; Unraveled Material; Material Protrusion/Extrusion; Flaked; Unraveled Material; Material Protrusion/Extrusion

  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 8936118 ↗
• MalfunctionAug 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION PROVIDED ON 12AUG2019 STATES THAT THE LEAK AT THE STOPCOCK WAS "DISCOVERED THE DAY AFTER DRAINAGE DUE TO A CONSTANT BUBBLING AND THE RADIOGRAPHY OF THE THORAX." THE STOPCOCK WAS REPLACED BY A NEW ONE IN AN ADDITIONAL PROCEDURE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8870660 ↗
• MalfunctionApr 19, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED DURING A NEONATAL CHEST DRAIN FOR PNEUMOTHORAX, THE FUHRMAN PLEURAL DRAINAGE SET¿S NEEDLE WAS PLACED AND THE WIRE WAS INSERTED. THE NEEDLE WAS REMOVED; HOWEVER, THE DILATOR WAS DIFFICULT TO PLACE OVER THE WIRE. UPON REMOVAL OF THE DILATOR, THE WIRE WAS UNINTENTIONALLY REMOVED AS WELL. INSPECTION OF THE WIRE AFTER REMOVAL FOUND A FEW PLACES WERE COATING WAS MISSING. IT WAS SUSPECTED THE MISSING COATING IS WHAT LED TO THE DILATOR INSERTION DIFFICULTY. TO DATE, ADDITIONAL INFORMATION REGARDING THE PATIENT STATUS OR EVENT DETAILS HAS NOT BEEN MADE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7443796 ↗
• MalfunctionMar 26, 2018Flaked; Peeled/Delaminated

  IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THE METALLIC GUIDE WAS FLAKING OFF PART OF THE FUHRMAN PLEURAL/PNEUMOPERICARDIA DRAINAGE SET. THE PHYSICIAN NOTED THERE WAS SOME GREEN PAINTING PEELING OFF WHEN THE GUIDE WAS ON THE DRAINAGE TUBE. A NEW DEVICE WAS USED FOR DRAINAGE ON THE PATIENT. THERE WAS NO PATIENT CONTACT OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7370123 ↗
• InjuryApr 5, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE FOR TREATMENT OF A PNEUMOTHORAX. THE REPORTER STATES THAT THE STAFF COULD NOT REMOVE THE GUIDEWIRE AFTER PLACEMENT OF THE DRAIN. THE STAFF THEN REMOVED THE DRAIN AND GUIDEWIRE AS A SINGLE UNIT. THE REPORTER STATED THAT THE GUIDEWIRE CAME THROUGH ONE OF THE HOLES AT THE END OF THE PIGTAIL AND WAS HOOKED AROUND THE OUTSIDE OF THE DRAIN. A REPLACEMENT DEVICE WAS OBTAINED AND THE PLACEMENT PROCEDURE COMPLETED. THE EVENT RESULTED IN A PROLONGED PROCEDURE AND DELAYED THE INFLATION OF THE COLLAPSED LUNG. NO FURTHER EVENT OR PATIENT INFORMATION WAS RECEIVED TO DATE.

  Patient problems: No Code Available

  MAUDE report 6460116 ↗