Closed Wound Suction 0043610Recalls & reported problems

Summary

The FDA's MAUDE database contains 303 adverse event reports that list this exact device (DI 00801741049354), received between Mar 29, 2017 and Sep 30, 2026 — classified as 40 injuries, 263 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (84 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 303 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Dull, Blunt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950945 ↗
• MalfunctionSep 30, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950944 ↗
• MalfunctionSep 30, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950943 ↗
• MalfunctionSep 30, 2026Dull, Blunt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950942 ↗
• MalfunctionSep 10, 2026Dull, Blunt

  It was reported that customer had concern in OR with two evacuators also felt the evacuators were dull than in the past. Material 0043610 and Material 0043620.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721014 ↗
• MalfunctionJul 30, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085782 ↗
• MalfunctionJun 5, 2026Disconnection

  IT WAS REPORTED THAT HEMOVAC TUBING FOR RIGHT BACK WOUND DRAIN CAME DISCONNECTED AFTER WORKING WITH PHYSIOTHERAPY, DISCONNECTED AT Y SITE. PATIENT EXPERIENCED UNEXPECTED OR PROLONGED CARE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25412866 ↗
• MalfunctionMay 28, 2026Disconnection

  IT WAS REPORTED BY CUSTOMER THAT THE 400 CC EVACUATION SYSTEM WITH 18 INCH POLYVINYL CHLORIDE TUBING AND TROCAR TUBING DISCONNECTION CAUSING BLOOD TO DRAIN ON THE PATIENT AND BED.

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325538 ↗
• MalfunctionMay 22, 2026Disconnection

  IT WAS REPORTED THAT THEY WERE NOTICED THE WOUND DRAIN RESERVOIRS ARE FELL OFF THE DRAIN TUBING, WHICH THEN LEADS TO DRAINS LEAKING, INACCURATE I & O MEASUREMENTS, AND A DIRECT PATH FOR INFECTION FROM AN OPEN DRAIN TUBE TO THE SURGICAL SITE. THEY HAD BEEN HAVING THAT ISSUE ON AND OFF FOR A WHILE WITH OUR DRAIN SO IF THEY COULD HAVE SOME HELP INVESTIGATING THE ISSUE WITH OUR DRAIN THAT WOULD BE HELPFUL. THEY ARE VERY OPEN TO GETTING ANY EXTRA TRAINING ON THAT OR ADVICE IF THEY WERE NOT USED THAT CORRECTLY WHICH WAS LEADING TO THOSE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262611 ↗
• MalfunctionMay 1, 2026Disconnection

  IT WAS REPORTED THAT THE 4 PATIENTS ON 4/15 HAD HEMOVAC DRAINS PLACED, AND ADMITTED OVERNIGHT, ALL 4 HEMOVACS HAD THE CONNECTION FROM SMALLER DRAIN TUBE TO LARGE DRAIN TUBE FAIL AND COME APART NOT DUE TO PATIENT MOVEMENT THIS HAPPENED BEFORE PATIENT GOT OUT OF BED. ALL HEMOVACS WHERE PLACED BY SURGEON OR PA WHO PLACE THESE ROUTINELY AND INVOLVED MULTIPLE SURGEONS. CONCERNED THAT THERE WAS AN ISSUE WITH THE DRAIN QUALITY AND SHOULD REPLACE THE LOT/BOX TO PREVENT FUTURE ISSUE AS IT CAUSED BLOOD TO SPILL ALL OVER BED/PATIENT, AND REQUIRED REPEATED MONITORING TO ENSURE THE DRAIN CONNECTION WOULD BE SECURE. IT WAS REINFORCED WITH TEGADERM.

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062161 ↗
• MalfunctionApr 30, 2026Disconnection

  IT WAS REPORTED THAT THE 4 PATIENTS ON (B)(6) 2026 HAD HEMOVAC DRAINS PLACED, AND ADMITTED OVERNIGHT, ALL 4 HEMOVACS HAD THE CONNECTION FROM SMALLER DRAIN TUBE TO LARGE DRAIN TUBE FAIL AND COME APART NOT DUE TO PATIENT MOVEMENT THIS HAPPENED BEFORE PATIENT GOT OUT OF BED. ALL HEMOVACS WHERE PLACED BY SURGEON OR PA WHO PLACE THESE ROUTINELY AND INVOLVED MULTIPLE SURGEONS. CONCERNED THAT THERE WAS AN ISSUE WITH THE DRAIN QUALITY AND SHOULD REPLACE THE LOT OR BOX TO PREVENT FUTURE ISSUE AS IT CAUSED BLOOD TO SPILL ALL OVER BED OR THE PATIENT, AND REQUIRED REPEATED MONITORING TO ENSURE THE DRAIN CONNECTION WOULD BE SECURE. IT WAS REINFORCED WITH TEGADERM.

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044849 ↗
• MalfunctionApr 30, 2026Disconnection

  IT WAS REPORTED THAT THE 4 PATIENTS ON (B)(6) 2026 HAD HEMOVAC DRAINS PLACED, AND ADMITTED OVERNIGHT, ALL 4 HEMOVACS HAD THE CONNECTION FROM SMALLER DRAIN TUBE TO LARGE DRAIN TUBE FAIL AND COME APART NOT DUE TO PATIENT MOVEMENT THIS HAPPENED BEFORE PATIENT GOT OUT OF BED. ALL HEMOVACS WHERE PLACED BY SURGEON OR PA WHO PLACE THESE ROUTINELY AND INVOLVED MULTIPLE SURGEONS. CONCERNED THAT THERE WAS AN ISSUE WITH THE DRAIN QUALITY AND SHOULD REPLACE THE LOT OR BOX TO PREVENT FUTURE ISSUE AS IT CAUSED BLOOD TO SPILL ALL OVER BED OR THE PATIENT, AND REQUIRED REPEATED MONITORING TO ENSURE THE DRAIN CONNECTION WOULD BE SECURE. IT WAS REINFORCED WITH TEGADERM.

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044841 ↗
• MalfunctionApr 30, 2026Disconnection

  IT WAS REPORTED THAT THE 4 PATIENTS ON 4/15 HAD HEMOVAC DRAINS PLACED, AND ADMITTED OVERNIGHT, ALL 4 HEMOVACS HAD THE CONNECTION FROM SMALLER DRAIN TUBE TO LARGE DRAIN TUBE FAIL AND COME APART NOT DUE TO PATIENT MOVEMENT THIS HAPPENED BEFORE PATIENT GOT OUT OF BED. ALL HEMOVACS WHERE PLACED BY SURGEON OR PA WHO PLACE THESE ROUTINELY AND INVOLVED MULTIPLE SURGEONS. CONCERNED THAT THERE WAS AN ISSUE WITH THE DRAIN QUALITY AND SHOULD REPLACE THE LOT/BOX TO PREVENT FUTURE ISSUE AS IT CAUSED BLOOD TO SPILL ALL OVER BED/PATIENT, AND REQUIRED REPEATED MONITORING TO ENSURE THE DRAIN CONNECTION WOULD BE SECURE. IT WAS REINFORCED WITH TEGADERM.

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044840 ↗
• MalfunctionMar 24, 2026Disconnection

  IT WAS REPORTED THAT THE PATIENT'S HEMOVAC SURGICAL BACK DRAIN BECAME DISCONNECTED FROM Y-SITE WHEN PATIENT WAS SITTING AT EDGE OF BED. TUBING CLAMPED WITH AND END KEPT STERILE WITH GAUZE. CLEANSED WITH CHLOROHEXADINE BEFORE REATTACHING TO A NEW STERILE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677636 ↗
• MalfunctionFeb 3, 2026Disconnection

  IT WAS REPORTED BY CUSTOMER THAT THE HEMOVAC HAS BEEN DISCONNECTED FROM THE BASE OF THE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254459 ↗
• MalfunctionFeb 2, 2026Nonstandard Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ADVENT HEALTH TAMPA WAS HAVING ISSUE WITH THE JP ROUND DRAINS. THEY ASKED BD REPRESENTATIVE TO CONTACT THEM VIA EMAIL OR CELL. SO, THEY CAN SET A TIME FOR BD REPRESENTATIVE TO COME OUT AND TROUBLE SHOOT AND SUPPORT THE TEAM. NO ITEMS ARE AVAILABLE TO SEND BACK, UNFORTUNATELY THEY WERE NOT SAVED. THE TEAM HAS BEEN ADVISED THAT OTHER DRAINS USED IN THE FUTURE AND DEEMED DYSFUNCTIONAL NEED TO BE SAVED. SINCE THE ITEMS WERE NOT SAVED, THERE IS NO LOT AVAILABLE, HOWEVER, ADVISED TO SEE IF ALL THE LOTS IN THE BIN ARE THE SAME AND PROVIDE THAT ONE. TYPICALLY, ADVENTHEALTH PROCESS FOR ITEMS THAT HAVE REQUIRED A PRODUCT FEEDBACK FORM IS THE PRODUCT REP COORDINATES A TIME WITH THE UNIT POINT PERSON TO TROUBLE SHOOT AND/OR PROVIDE EDUCATION AND TRAINING IF APPLICABLE. THEY ASKED BD REPRESENTATIVE TO SPEAK WITH TO MAKE A DECISION ON WHAT WOULD BE BEST FOR THE UNIT STAFF, PATIENTS, AND SURGEONS. THEY WERE ABLE TO LOCATE THE DRAINS IN THE BIN AND UNFORTUNATELY DUE TO THE ACTUAL DRAIN WRAPPER NOT SAVED, THEY CANNOT BE TOTALLY CERTAIN WHICH WAS USED. THEY DID, HOWEVER FOUND THREE DIFFERENT LOT# NGKV2882, LOT# NGJX0309, LOT#NGJX6142.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24230818 ↗
• MalfunctionJan 30, 2026Nonstandard Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT A CUSTOMER WAS HAVING ISSUE WITH THE JP ROUND DRAINS. THEY ASKED A REPRESENTATIVE TO CONTACT THEM VIA EMAIL OR CELL SO THEY CAN SET A TIME FOR A REPRESENTATIVE TO COME OUT AND TROUBLE SHOOT AND SUPPORT THE TEAM. NO ITEMS ARE AVAILABLE TO SEND BACK, UNFORTUNATELY THEY WERE NOT SAVED. THE TEAM HAS BEEN ADVISED THAT OTHER DRAINS USED IN THE FUTURE AND DEEMED DYSFUNCTIONAL NEED TO BE SAVED. SINCE THE ITEMS WERE NOT SAVED, THERE IS NO LOT AVAILABLE, HOWEVER, ADVISED TO SEE IF ALL THE LOTS IN THE BIN ARE THE SAME AND PROVIDE THAT ONE. TYPICALLY, THEY PROCESS ITEMS THAT HAVE REQUIRED A PRODUCT FEEDBACK FORM IF THE PRODUCT REP COORDINATES A TIME WITH THE UNIT POINT PERSON TO TROUBLE SHOOT AND OR PROVIDE EDUCATION AND TRAINING IF APPLICABLE. THEY ASKED FOR A REPRESENTATIVE TO SPEAK WITH TO MAKE A DECISION ON WHAT WOULD BE BEST FOR THE UNIT STAFF, PATIENTS, AND SURGEONS. THEY WERE ABLE TO LOCATE THE DRAINS IN THE BIN AND UNFORTUNATELY DUE TO THE ACTUAL DRAIN WRAPPER NOT BEING SAVED, THEY CANNOT BE TOTALLY CERTAIN WHICH WAS USED. THEY DID, HOWEVER FIND THREE DIFFERENT LOT NGKV2882, LOT NGJX0309, AND LOT NGJX6142.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228795 ↗
• MalfunctionJan 30, 2026Nonstandard Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ADVENT HEALTH TAMPA WAS HAVING ISSUE WITH THE JP ROUND DRAINS. THEY ASKED BD REPRESENTATIVE TO CONTACT THEM VIA EMAIL OR CELL. SO, THEY CAN SET A TIME FOR BD REPRESENTATIVE TO COME OUT AND TROUBLE SHOOT AND SUPPORT THE TEAM. NO ITEMS ARE AVAILABLE TO SEND BACK, UNFORTUNATELY THEY WERE NOT SAVED. THE TEAM HAS BEEN ADVISED THAT OTHER DRAINS USED IN THE FUTURE AND DEEMED DYSFUNCTIONAL NEED TO BE SAVED. SINCE THE ITEMS WERE NOT SAVED, THERE IS NO LOT AVAILABLE, HOWEVER, ADVISED TO SEE IF ALL THE LOTS IN THE BIN ARE THE SAME AND PROVIDE THAT ONE. TYPICALLY, ADVENTHEALTH PROCESS FOR ITEMS THAT HAVE REQUIRED A PRODUCT FEEDBACK FORM IS THE PRODUCT REP COORDINATES A TIME WITH THE UNIT POINT PERSON TO TROUBLE SHOOT AND/OR PROVIDE EDUCATION AND TRAINING IF APPLICABLE. THEY ASKED BD REPRESENTATIVE TO SPEAK WITH AND MAKE A DECISION ON WHAT WOULD BE BEST FOR THE UNIT STAFF, PATIENTS, AND SURGEONS. THEY WERE ABLE TO LOCATE THE DRAINS IN THE BIN AND UNFORTUNATELY DUE TO THE ACTUAL DRAIN WRAPPER NOT SAVED, THEY CANNOT BE TOTALLY CERTAIN WHICH WAS USED. THEY DID, HOWEVER FOUND THREE DIFFERENT LOT# NGKV2882, LOT# NGJX0309, LOT#NGJX6142.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228794 ↗
• MalfunctionJan 30, 2026Collapse

  IT WAS REPORTED THAT DURING A CLOSED SPINE SURGERY, THE TEAM HAD TO GO THROUGH THREE DIFFERENT DRAINS FOR ONE PATIENT BECAUSE THE DRAINS WERE NOT FUNCTIONING PROPERLY. EACH WOUND DRAIN KEPT CLOSING OR COLLAPSING. WHEN A DRAIN WAS NOT WORKING AS INTENDED, BLOOD AND FLUID CAN BUILD UP INSTEAD OF BEEN REMOVED. THAT CAN LEAD TO A HEMATOMA, WHICH INCREASES THE RISK OF INFECTION, ESPECIALLY IN A SURGICAL SETTING. PER ADDITIONAL INFORMATION RECEIVED AN EMAIL ON 27JAN2026 STATED THAT PHONE CALL FROM THE NEURO/SPINE COORDINATOR AT ADVENTHEALTH TAMPA, WHO SHARED FURTHER DETAILS ABOUT THE ISSUE AND EXPLAINED THAT THE PROBLEM THEY EXPERIENCED WITH ITEM #0043610 ¿ EVAC 400CC-3 SPRING 1/8 WAS THAT THE THREE-SPRING EVACUATOR WAS NOT FUNCTIONING PROPERLY. THE EVACUATOR WOULD NOT STAY COMPRESSED, WHICH PREVENTED THE DRAIN FROM WORKING AS INTENDED. IT WOULD NOT MAINTAIN A PROPER SEAL AND THAT'S WHY THEY TRIED USING 3 DIFFERENT DRAINS. AND ALSO MENTIONED THAT THEY WERE ABLE TO LOCATE THE DRAINS IN THE BIN AFTERWARD; HOWEVER, BECAUSE THE ORIGINAL WRAPPER WAS NOT SAVED, THEY CANNOT CONFIRM WITH CERTAINTY WHICH UNIT WAS USED OR THE ASSOCIATED LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223860 ↗
• MalfunctionJan 30, 2026Collapse; Decrease in Suction

  IT WAS REPORTED THAT DURING A CLOSED SPINE SURGERY, THE TEAM HAD TO GO THROUGH THREE DIFFERENT DRAINS FOR ONE PATIENT BECAUSE THE DRAINS WERE NOT FUNCTIONING PROPERLY. EACH WOUND DRAIN KEPT CLOSING OR COLLAPSING. WHEN A DRAIN WAS NOT WORKING AS INTENDED, BLOOD AND FLUID CAN BUILD UP INSTEAD OF BEEN REMOVED. THAT CAN LEAD TO A HEMATOMA, WHICH INCREASES THE RISK OF INFECTION, ESPECIALLY IN A SURGICAL SETTING. PER ADDITIONAL INFORMATION RECEIVED AN EMAIL ON 27JAN2026 STATED THAT PHONE CALL FROM THE NEURO/SPINE COORDINATOR AT ADVENTHEALTH TAMPA, WHO SHARED FURTHER DETAILS ABOUT THE ISSUE AND EXPLAINED THAT THE PROBLEM THEY EXPERIENCED WITH ITEM #0043610 ¿ EVAC 400CC-3 SPRING 1/8 WAS THAT THE THREE-SPRING EVACUATOR WAS NOT FUNCTIONING PROPERLY. THE EVACUATOR WOULD NOT STAY COMPRESSED, WHICH PREVENTED THE DRAIN FROM WORKING AS INTENDED. IT WOULD NOT MAINTAIN A PROPER SEAL AND THAT'S WHY THEY TRIED USING 3 DIFFERENT DRAINS. AND ALSO MENTIONED THAT THEY WERE ABLE TO LOCATE THE DRAINS IN THE BIN AFTERWARD; HOWEVER, BECAUSE THE ORIGINAL WRAPPER WAS NOT SAVED, THEY CANNOT CONFIRM WITH CERTAINTY WHICH UNIT WAS USED OR THE ASSOCIATED LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223859 ↗
• MalfunctionJan 28, 2026Material Fragmentation

  IT WAS REPORTED THAT THE HOSPITAL USER STATED THAT THEY COULD REACH OUT TO THEM AND TO COORDINATE SOME EDUCATIONAL INFORMATION ON THE HEMOVAC DRAINS. THEY HAD A SECOND DRAIN BREAK AT THE Y-PORT SITE. THEY WOULD LIKE TO ENSURE EDUCATION AND POTENTIAL PRODUCT FAILURE WAS NOT AN ISSUE. PER FOLLOW UP INFORMATION RECEIVED ON 16JAN2026, STATED THAT 1 PATIENT RETURNED FOR NEW DRAIN PLACEMENT. 1 WAS ABLE TO BE PIECED TOGETHER ENOUGH TO CONTINUE WORKING. THE PATIENT RETURNED TO SURGERY. THE Y-SITE SHATTERED, UNABLE TO TROUBLESHOOT. NO PATIENT IDENTIFIERS. THE TWO LOTS WERE NGKT1705 AND NGKN3419. NO PHYSICAL SAMPLES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206297 ↗
• MalfunctionJan 28, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TWO HEMOVAC DRAINS ON THE SAME PATIENT HAVE CRACKED/SPLIT OPEN IN-BETWEEN THE "Y" SITE WHERE THE TUBE FROM THE PATIENT CONNECTS TO THE TUBING OF THE HEMOVAC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206103 ↗
• InjuryJan 16, 2026Partial Blockage

  IT WAS REPORTED BY PA WORKING WITH THE DOCTOR THAT THE PRODUCT NUMBER IS 0043610. THEY WANTED TO SEND SOME BACKGROUND INFO THAT WAS SENT FROM THE PA WHO WORKS WITH THESE DRAINS TO OUR ORIGINAL POINT OF CONTACT FOR A BETTER OVERALL PICTURE OF OUR ISSUES. IT IS NOT ONLY THE TROCAR, BUT NOW THE CLOTTING ISSUE. THERE HAVE NOW BEEN 2 PATIENTS WHO HAVE FORMED HEMATOMAS. THEY HAVE A FEW CONCERNS ABOUT THE DRAIN THEY HAVE BEEN USING. THE 1ST PROBLEM THAT THEY NOTICED WITH THE DRAIN WAS THAT, WHEN THEY TRIED TO PIERCE THROUGH THE SKIN, THE DRAIN TROCAR WAS NOT SHARP ENOUGH AND I HAD DIFFICULTY ACTUALLY PIERCING THE SKIN. THEY HAVE HAD TO USE MY FINGERS TO PRESS DOWN ON THE SKIN, AS WELL AS MULTIPLE INSTRUMENTS, AND SOMETIMES THEY HAVE DIFFICULTY EVEN DOING THAT. DUE TO THIS DIFFICULTY, THEY HAVE ALMOST POKED THEMSELF WITH THE DRAIN TROCAR MULTIPLE TIMES. THEY WERE VERY CAREFUL IN SURGERY, AND THIS HAS BOTHERED THEM QUITE A BIT BECAUSE THEY DO NOT WANT TO GET POKED AS WELL AS DO NOT WANT TO CAUSE ANY RISK OF CONTAMINATION TO THE PATIENT. THEY HAVE NOW BROKEN 2 NEEDLE DRIVERS TRYING TO PUNCTURE THROUGH THE SKIN WITH THE DRAIN TROCAR. IT WAS JUST BROUGHT TO THEIR ATTENTION TODAY THAT THE DOCTO

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 24093073 ↗
• MalfunctionJan 16, 2026Partial Blockage

  IT WAS REPORTED BY PA WORKING WITH THE DOCTOR THAT THE PRODUCT NUMBER IS 0043610. THEY WANTED TO SEND SOME BACKGROUND INFO THAT WAS SENT FROM THE PA WHO WORKS WITH THESE DRAINS TO OUR ORIGINAL POINT OF CONTACT FOR A BETTER OVERALL PICTURE OF OUR ISSUES. IT IS NOT ONLY THE TROCAR, BUT NOW THE CLOTTING ISSUE. THERE HAVE NOW BEEN 2 PATIENTS WHO HAVE FORMED HEMATOMAS. THEY HAVE A FEW CONCERNS ABOUT THE DRAIN THEY HAVE BEEN USING. THE 1ST PROBLEM THAT THEY NOTICED WITH THE DRAIN WAS THAT, WHEN THEY TRIED TO PIERCE THROUGH THE SKIN, THE DRAIN TROCAR WAS NOT SHARP ENOUGH AND I HAD DIFFICULTY ACTUALLY PIERCING THE SKIN. THEY HAVE HAD TO USE MY FINGERS TO PRESS DOWN ON THE SKIN, AS WELL AS MULTIPLE INSTRUMENTS, AND SOMETIMES THEY HAVE DIFFICULTY EVEN DOING THAT. DUE TO THIS DIFFICULTY, THEY HAVE ALMOST POKED THEMSELF WITH THE DRAIN TROCAR MULTIPLE TIMES. THEY WERE VERY CAREFUL IN SURGERY, AND THIS HAS BOTHERED THEM QUITE A BIT BECAUSE THEY DO NOT WANT TO GET POKED AS WELL AS DO NOT WANT TO CAUSE ANY RISK OF CONTAMINATION TO THE PATIENT. THEY HAVE NOW BROKEN 2 NEEDLE DRIVERS TRYING TO PUNCTURE THROUGH THE SKIN WITH THE DRAIN TROCAR. IT WAS JUST BROUGHT TO THEIR ATTENTION TODAY THAT THE DOCTO

  Patient problems: Hematoma

  MAUDE report 24093070 ↗
• MalfunctionJan 16, 2026Dull, Blunt

  IT WAS REPORTED BY PA WORKING WITH THE DOCTOR THAT THE PRODUCT NUMBER IS 0043610. THEY WANTED TO SEND SOME BACKGROUND INFO THAT WAS SENT FROM THE PA WHO WORKS WITH THESE DRAINS TO OUR ORIGINAL POINT OF CONTACT FOR A BETTER OVERALL PICTURE OF OUR ISSUES. IT IS NOT ONLY THE TROCAR, BUT NOW THE CLOTTING ISSUE. THERE HAVE NOW BEEN 2 PATIENTS WHO HAVE FORMED HEMATOMAS. THEY HAVE A FEW CONCERNS ABOUT THE DRAIN THEY HAVE BEEN USING. THE 1ST PROBLEM THAT THEY NOTICED WITH THE DRAIN WAS THAT, WHEN THEY TRIED TO PIERCE THROUGH THE SKIN, THE DRAIN TROCAR WAS NOT SHARP ENOUGH AND I HAD DIFFICULTY ACTUALLY PIERCING THE SKIN. THEY HAVE HAD TO USE MY FINGERS TO PRESS DOWN ON THE SKIN, AS WELL AS MULTIPLE INSTRUMENTS, AND SOMETIMES THEY HAVE DIFFICULTY EVEN DOING THAT. DUE TO THIS DIFFICULTY, THEY HAVE ALMOST POKED THEMSELF WITH THE DRAIN TROCAR MULTIPLE TIMES. THEY WERE VERY CAREFUL IN SURGERY, AND THIS HAS BOTHERED THEM QUITE A BIT BECAUSE THEY DO NOT WANT TO GET POKED AS WELL AS DO NOT WANT TO CAUSE ANY RISK OF CONTAMINATION TO THE PATIENT. THEY HAVE NOW BROKEN 2 NEEDLE DRIVERS TRYING TO PUNCTURE THROUGH THE SKIN WITH THE DRAIN TROCAR. IT WAS JUST BROUGHT TO THEIR ATTENTION TODAY THAT THE DOCTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093069 ↗