Closed Wound Suction 0070740Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 00801741049569), received between Apr 11, 2017 and Jul 14, 2026 — classified as 5 injuries, 187 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (67 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 25 most recent of 192 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Fitting Problem

  IT WAS REPORTED THAT THE WOUND DRAINS WERE NOT SEALING BETWEEN THE EVACUATOR AND THE DRAIN, MAKING IT UNABLE TO COMPLETE THE TASK, AND ALSO MAKING THE PRODUCT TO PERFORM NOT AS INTENDED. LOT NGLN1260.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812540 ↗
• MalfunctionJul 14, 2026Fitting Problem

  IT WAS REPORTED THAT THE WOUND DRAINS WERE NOT SEALING BETWEEN THE EVACUATOR AND THE DRAIN, MAKING IT UNABLE TO COMPLETE THE TASK, AND ALSO MAKING THE PRODUCT TO PERFORM NOT AS INTENDED. LOT NGKZ1251.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812533 ↗
• MalfunctionMay 5, 2026Disconnection; Material Fragmentation

  IT WAS REPORTED THAT THE 100 CC SILICONE CLOSED WOUND SUCTION EVACUATOR TOP KEEPS POPPING OFF. THIS HAPPENED LAST NIGHT TO THE PATIENT WITH BOTH OF HER BULBS. THE BULBS CONTINUE TO POP OPEN ONCE THE PATIENT GETS TO THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088829 ↗
• MalfunctionMay 3, 2026Disconnection

  IT WAS REPORTED THAT THE BULB EVACUATORS WERE UNCAPPING WHEN THE PATIENT MADE IT BACK TO THEIR FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062494 ↗
• MalfunctionMar 17, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD ADVISED 3 FOLEY CATHETERS FROM THE SAME LOT; ALL BALLOONS HAD BURST WITHIN A FEW HOURS OF INSERTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621876 ↗
• MalfunctionMar 17, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS UNUSED, FOREIGN MATTER ADHERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621743 ↗
• MalfunctionJan 12, 2026Scratched Material

  IT WAS REPORTED THAT THE WOUND DRAINS MAIN UNIT HAD DIRT OR SCRATCHES UPON OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046160 ↗
• MalfunctionJan 12, 2026Material Fragmentation

  IT WAS REPORTED THAT THE EXTERNAL PORTION OF THE WOUND DRAIN TUBING WAS SNAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031608 ↗
• MalfunctionJan 8, 2026Decrease in Suction

  IT WAS REPORTED THAT WOUND DRAIN VALVE WAS NOT ALLOWING SUCTION AND COULD CAUSE PATIENT HARM IF THE MEDICAL TEAM THOUGHT THERE WAS NO DRAINAGE AND THE DRAIN WAS REMOVED. (LOT- UNK) AND (LOT - NGKU3981).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005780 ↗
• MalfunctionJan 8, 2026Decrease in Suction

  IT WAS REPORTED THAT WOUND DRAIN VALVE WAS NOT ALLOWING SUCTION AND COULD CAUSE PATIENT HARM IF THE MEDICAL TEAM THOUGHT THERE WAS NO DRAINAGE AND THE DRAIN WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005774 ↗
• MalfunctionDec 29, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE WOUND DRAINS MAIN UNIT HAD DIRT OR SCRATCHES UPON OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23916979 ↗
• MalfunctionNov 13, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN USED A SYRINGE TO DRAW FLUID FROM THE EVACUATOR DRAINAGE PORT, AND TRIED TO REMOVE THE SYRINGE, THE BASE OF THE DRAINAGE PORT BROKE OFF AND DIDN'T APPLY ANY EXTRA FORCE, DID IT THE USUAL WAY. THE WASTE FLUID PORT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543781 ↗
• MalfunctionNov 6, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS DEBRIS AND HAIRS IN THE SILICONE DRAIN EVACUATOR. PER CUSTOMER VIA EMAIL ON 14AUG2025 IT WAS REPORTED THAT A TOTAL OF 17 SILICONE DRAIN EVACUATORS CONTAINED DEBRIS. SAMPLE IS AVAILABLE. PENDING SAMPLE RETURN. NO FURTHER DETAILS WERE PROVIDED. PER SAMPLE EVALUATION, FOREIGN MATERIAL WAS FOUND. LOT: NGKQ0974; RELEASE DATE: 04/09/2025; EXPIRATION DATE: 02/28/2030.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488204 ↗
• MalfunctionOct 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE WOUND DRAIN EVACUATOR WAS CONTAMINANT IN SEALED PACKAGE. PER CUSTOMER EMAIL RESPONSE RECEIVED ON 18DEC2025. IT WAS REPORTED THAT THE PHYSICAL SAMPLE IS STILL AVAILABLE. PENDING SAMPLE RETURN. THE CONTAMINANT IS LOCATED IN THE CORNER OF THE PACKAGE AND WAS FOUND BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390554 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED SEVERE POSTOPERATIVE INFECTION (SEPSIS) REQUIRING FIVE ADDITIONAL SURGERIES FOLLOWING BILATERAL MASTECTOMY. PATIENT EXPERIENCED LIFE-THREATENING INFECTION, WEEKLONG HOSPITALIZATION, REMOVAL OF RECONSTRUCTION AND 5 REOPERATIONS DUE TO SEVERE SCARRING AND TISSUE DAMAGE, PROLONGED RECOVERY, PAIN/SUFFERING, FINANCIAL LOSS, EMOTIONAL AND PHYSICAL TRAUMA. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2025, IT WAS REPORTED THAT PATIENT ENDED UP HAVING TO HAVE SURGERY DURING MY HOSPITAL STAY FOR REMOVAL OF THE RECONSTRUCTED BREAST AND DAMAGED TISSUE DUE TO THE GRAM NEGATIVE SERRATIA MARCESCENS BACTERIAL INFECTION FROM DRAINS. THE PATIENT ENDED UP HAVING TO ONLY HAVE ONE BREAST FOR A FEW MONTHS WHILE TISSUE HEALED. THEN UNDERWENT THE EXPANDER PROCEDURE AND 5 SURGERIES TO TRY AND RE-RECONSTRUCT THAT SIDE OF MY CHEST. IT STILL HAS COMPLICATIONS AND THE DAMAGED TISSUE/SCAR TISSUE ISN¿T ALLOWING AN IMPLANT TO STAY IN PLACE SO THE BREAST RECONSTRUCTION ISN¿T HOLDING AND I HAVE TO GO BACK FOR MORE SURGERIES TO FIX. MY BODY NEEDED A BREAK THOUGH BECAUSE THE INFECTION AND MULTIPLE SURGERIES TOOK A HAVOC ON MY IMMUNE SYSTEM AND BLOOD COUNTS. I WILL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Sepsis; Unspecified Infection

  MAUDE report 23381288 ↗
• MalfunctionOct 8, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE USE THE EVACUATOR COMPONENT ATTACHED TO THE UPPER PART OF THE BAG WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23243859 ↗
• InjurySep 22, 2025Partial Blockage; Disconnection; Partial Blockage; Disconnection

  IT WAS REPORTED THAT THE PATIENT ARRIVED IN CLINIC THIS MORNING AFTER SPEAKING TO A TRIAGE NURSE REGARDING HER DRAIN. PATIENT STATED SHE CALLED OUR TRIAGE LINE AT 230AM REGARDING HER DRAIN NOT DRAINING AND THEN ONCE SHE STRIPPED THE LINE A COUPLE TIMES, SOMETHING CAME OFF IN THE BULB. SHE WAS TOLD BY THE NURSE TO COME INTO THE CLINIC THIS MORNING. BROUGHT PATIENT BACK TO CHECK HER DRAIN. ON EXAM, THE SUCTION VALVE ON THE INSIDE OF THE BULB HAD POPPED OFF AND WAS AT THE BOTTOM OF THE BULB. IT LOOKS LIKE THERE WAS SOME TISSUE DEBRIS THAT GOT STUCK THE IN-SUCTION VALVE WHICH HAD BLOCKED THE DRAIN FROM DRAINING PROPERLY. EMPTIED BULB AND REPLACED IT WITH A NEW ONE. I TOLD THE PATIENT THAT IF ANYTHING HAPPENS OVER THE WEEKEND TO CALL TRIAGE AND JUST ASK FOR THE ON-CALL BREAST SURGEON.

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

  MAUDE report 23115754 ↗
• MalfunctionSep 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE 10FR ROUND DRAINS. THEY OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS, AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS, AND THE THIRD ONE HAD FUZZY SUBSTANCE AND HAIR INSIDE THE STERILE PACKAGING. REFERENCE NUMBER (B)(4). ALL 3 PACKAGES HAD SAME LOT NUMBER NGKP0821. SURGEON HAS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE ACROSS ALL OPERATING ROOMS LD, BL, BW.1. THEY FOUND DEBRIS, POWDER-LIKE SUBSTANCES ON THEM AND VERY OFTEN THE DRAINS HAD SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN (LOT- NGJW3604). IT WAS SO FREQUENT THAT SURGEON HAD THE STAFF CHECK THE TUBING BEFORE THEY INSERT THEM. ACCORDING TO SOME, THEY SAW THAT ACROSS DRAIN SIZES. NOT SURE IF SOMETHING IN MANUFACTURING CHANGED AND THERE HAD BEEN TWO TIMES THAT THE DRAINS DID NOT FUNCTION AT THE END OF THE CASE. AFTER INVESTIGATING, THE SAME CLEAR GEL THAT WAS AT THE END OF THE DRAIN BY THE TROCAR FILLED THE FLUTED PART OF THE DRAIN AS WELL SO THAT IT COULD NOT HOLD SUCTION. SURGEON HAD STAFF FLUSH ALL THE DRAINS BEFORE PLACEMENT AND CLOSED THE INCISION, SO THEY KNEW IT FUNCTION (LOT - NGJW3604). EMI HAD FOUR DRAINS THAT WERE SENT TO PRODUCT DEFECT TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074984 ↗
• MalfunctionSep 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THE BD 10FR ROUND DRAINS - WE OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS AND THE THIRD ONE HAD FUZZY SUBSTANCE AND A HAIR INSIDE THE STERILE PACKAGING. REFERENCE NUMBER 072221. ALL (3 PACKAGES) HAD SAME LOT NUMBER: NGKP0821 SURGEON HAS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE ACROSS ALL OPERATING ROOMS LD, BL, BW. 1. WE ARE FINDING DEBRIS, POWDER- LIKE SUBSTANCE ON THEM. 2. VERY OFTEN THE DRAINS HAVE SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN. IT IS SO FREQUENT THAT SURGEON HAS THE STAFF CHECK THE TUBING BEFORE WE INSERT THEM. ACCORDING TO SOME, THEY SEE THIS ACROSS DRAIN SIZES. NOT SURE IF SOMETHING IN THE MANUFACTURING CHANGED. 3. THERE HAVE BEEN TWO TIMES THAT THE DRAINS DID NOT FUNCTION AT THE END OF THE CASE. AFTER INVESTIGATING, THE SAME CLEAR JELL THAT IS AT THE END OF THE DRAIN BY THE TROCAR WAS FILLING THE FLUTED PART OF THE DRAIN AS WELL SO IT WAS NOT ABLE TO HOLD SUCTION. SURGEON IS HAVING STAFF FLUSH ALL THE DRAINS NOW BEFORE PLACEMENT AND CLOSE THE INCISION, SO WE KNOW THEY FUNCTION. EMI HAS FOUR DRAINS THAT SHE IS SENDING TO PRODUCT DEFECT TODAY [D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074980 ↗
• MalfunctionSep 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THE BD 10FR ROUND DRAINS - WE OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS AND THE THIRD ONE HAD FUZZY SUBSTANCE AND A HAIR INSIDE THE STERILE PACKAGING. REFERENCE NUMBER: (B)(4). ALL (3 PACKAGES) HAD SAME LOT NUMBER: NGKP0821. SURGEON HAS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE ACROSS ALL OPERATING ROOMS LD, BL, BW. 1. WE ARE FINDING DEBRIS, POWDER- LIKE SUBSTANCE ON THEM. 2. VERY OFTEN THE DRAINS HAVE SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN. IT IS SO FREQUENT THAT SURGEON HAS THE STAFF CHECK THE TUBING BEFORE WE INSERT THEM. ACCORDING TO SOME, THEY SEE THIS ACROSS DRAIN SIZES. NOT SURE IF SOMETHING IN THE MANUFACTURING CHANGED. 3. THERE HAVE BEEN TWO TIMES THAT THE DRAINS DID NOT FUNCTION AT THE END OF THE CASE. AFTER INVESTIGATING, THE SAME CLEAR JELL THAT IS AT THE END OF THE DRAIN BY THE TROCAR WAS FILLING THE FLUTED PART OF THE DRAIN AS WELL SO IT WAS NOT ABLE TO HOLD SUCTION. SURGEON IS HAVING STAFF FLUSH ALL THE DRAINS NOW BEFORE PLACEMENT AND CLOSE THE INCISION, SO WE KNOW THEY FUNCTION. EMI HAS FOUR DRAINS THAT SHE IS SENDING TO PRODUCT DEFECT TODAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074620 ↗
• MalfunctionSep 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE 10FR ROUND DRAINS. THEY OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS, AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS, AND THE THIRD ONE HAD FUZZY SUBSTANCE AND HAIR INSIDE THE STERILE PACKAGING. REFERENCE NUMBER: (B)(4). ALL 3 PACKAGES HAD SAME LOT NUMBER: NGKP0821. SURGEON HAS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE ACROSS ALL OPERATING ROOMS LD, BL, BW.1. THEY FOUND DEBRIS, POWDER-LIKE SUBSTANCES ON THEM AND VERY OFTEN THE DRAINS HAD SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN (LOT: NGJW3604). IT WAS SO FREQUENT THAT SURGEON HAD THE STAFF CHECK THE TUBING BEFORE THEY INSERT THEM. ACCORDING TO SOME, THEY SAW THAT ACROSS DRAIN SIZES. NOT SURE IF SOMETHING IN MANUFACTURING CHANGED AND THERE HAD BEEN TWO TIMES THAT THE DRAINS DID NOT FUNCTION AT THE END OF THE CASE. AFTER INVESTIGATING, THE SAME CLEAR GEL THAT WAS AT THE END OF THE DRAIN BY THE TROCAR FILLED THE FLUTED PART OF THE DRAIN AS WELL SO THAT IT COULD NOT HOLD SUCTION. SURGEON HAD STAFF FLUSH ALL THE DRAINS BEFORE PLACEMENT AND CLOSED THE INCISION, SO THEY KNEW IT FUNCTION (LOT: NGJW3604). EMI HAD FOUR DRAINS THAT WERE SENT TO PRODUCT DEFECT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074618 ↗
• MalfunctionSep 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WOUND DRAIN PRODUCT HAD BLACK PARTICLES NOTED INSIDE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23047810 ↗
• MalfunctionAug 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER WAS RECEIVED ONE PACKAGE OF WOUND DRAIN PRODUCT REF # (B)(4) WITH A HAIR PACKAGED INSIDE WITH PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895801 ↗
• MalfunctionAug 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS DEBRIS AND HAIRS IN THE SILICONE DRAIN EVACUATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749016 ↗
• MalfunctionJul 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE THE EVACUATOR VALVE INSIDE WAS BROKEN AND PHOTO ATTACHED. THE USER WAS EXPOSED TO BODILY FLUID. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 30JUL2025, STATED THAT NO PATIENT IMPACTED AND NO SERIOUS INJURIES THAT OCCUR TO THE PATIENT.

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

  MAUDE report 22667921 ↗