DUO-VENT 1C8043Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00085412019994), received between Jun 19, 2018 and Dec 15, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NITROGLYCERIN SETS LEAKED. THE SET WOULD BEND AND SEPARATE ¿WHERE THE SOFT TUBING MEETS THE HARD PLASTIC OF THE LUER ADAPTER COULD BE PULLED APART BY HAND.¿ THE SET WOULD LEAK DUE TO THE SEPARATION. IT IS UNKNOWN IF A POWER INJECTOR WAS USED. THE ISSUE WAS OBSERVED DURING SETUP IN THE PHARMACY DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810599 ↗
• MalfunctionDec 15, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NITROGLYCERIN SETS LEAKED. THE SET WOULD BEND AND SEPARATE ¿WHERE THE SOFT TUBING MEETS THE HARD PLASTIC OF THE LUER ADAPTER COULD BE PULLED APART BY HAND.¿ THE SET WOULD LEAK DUE TO THE SEPARATION. IT IS UNKNOWN IF A POWER INJECTOR WAS USED. THE ISSUE WAS OBSERVED DURING SETUP IN THE PHARMACY DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810506 ↗
• MalfunctionDec 15, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PE LINED SOLUTION SET LEAKED DURING PATIENT INFUSION. THE ISSUE WAS FURTHER DESCRIBED AS 'LIPIDS LEAKING THROUGH THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE AT THE PUMP SITE.' WHEN THE PUMP WAS OPENED TO CHECK THE LINE, IT WAS DISCOVERED THAT THE INTRAVENOUS (IV) TUBING WAS CRACKED AND LEAKING AT THE POINT WHERE THE IV TUBING WAS INSERTED INTO THE PUMP. THE TUBING WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810210 ↗
• MalfunctionApr 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NITROGLYCERIN SET HAD A LEAK DOWN THE TUBING WHERE THE WHITE PART OF THE TUBING (BUSHING) MEETS THE CLEAR TUBING. THIS WAS OBSERVED BY THE PATIENT DURING INFUSION. THE TUBING WAS PRIMED WITH DEXTROSE AND THE NURSE HUNG AN OXALIPLATIN INFUSION IN THE PUMP AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741097 ↗
• MalfunctionFeb 7, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE LUER LOCK ON THE END OF A NITROGLYCERIN SET WOULD NOT SCREW DOWN ONTO THE MALE ADAPTER OF AN UNSPECIFIED SALINE LOCK. THIS WAS IDENTIFIED DURING SET UP. A CLAMP WAS USED TO LOOSEN THE FITTING (COLLAR); HOWEVER, THE FITTING DID NOT LOOSEN. A NEW SET WAS USED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16314803 ↗
• MalfunctionJul 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A NITROGLYCERIN SET LEAKED "WHERE THE SOFT PLASTIC LINE MEETS THE HARD PLASTIC LUMEN". THIS ISSUE WAS IDENTIFIED DURING ADMINISTRATION OF PACLITAXEL 130 MG/250 ML NS. IT WAS FURTHER STATED THE LEAK OCCURRED APPROXIMATELY THIRTY MINUTES INTO THE INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238826 ↗
• MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NITROGLYCERIN SET WITH DUO-VENT SPIKE LEAKED AT THE "WHITE CONNECTION PIECE IN THE MIDDLE OF THE LINE". THIS OCCURRED DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12019126 ↗
• MalfunctionFeb 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) VENTED NITROGLYCERIN SETS BROKE DURING PRIMING, LEADING TO A LEAK. WHEN THE NURSE HUNG THE BAG FOR THE FIRST SET, THERE WAS SALINE LEAKING FROM THE LINE AND THE NURSE NOTICED THAT THE SET WAS BROKEN. THE SET WAS REPLACED WITH A NEW SET, THE NEW SET WAS PRIMED, AND THE SAME SECTION OF THE SECOND SET ALSO BROKE AND LEAKED. A THIRD SET WAS THEN PREPARED, AND NO ISSUES OR BREAKS WERE NOTED WITH THE THIRD SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8363242 ↗
• MalfunctionFeb 8, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT A NITROGLYCERIN SET THAT CAME APART. THE CUSTOMER LIGHTLY TUGGED THE DEVICE AND THE SET SEPARATED WHERE THE TUBING ATTACHED TO THE LUER CONNECTOR. THIS EVENT OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8323651 ↗
• MalfunctionFeb 7, 2019Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE TUBING OF TWO (2) NITROGLYCERIN SETS WITH DUO-VENT SPIKES SEPARATED FROM THEIR LUER ACCESS DEVICES; FURTHER DESCRIBED AS ¿IT BROKE WHERE THE TUBING SEGMENT ATTACHED TO THE LUER ACCESS DEVICE¿. THE SETS CAME APART WHEN THE CUSTOMER OPENED THE SET PACKAGE TO TEST THE SET AND LIGHTLY TUGGED IT. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE..

  Patient problems: No Patient Involvement

  MAUDE report 8318774 ↗
• MalfunctionJan 23, 2019Break; Fluid/Blood Leak

  PATIENT'S MEDICATION WAS PREPARED BY PHARMACY THAT REQUIRED A 3-PIECE SET BE ATTACHED, IT WAS THEN DELIVERED TO INFUSION POD. THE NURSE RETURNED TO THE WINDOW WITH IT TO SHOW THAT PART OF THE LINE WAS BROKEN AND WHEN SHE HUNG THE BAG THERE WAS SALINE LEAKING FROM THE LINE. THE SET THAT WAS BROKEN WAS 1C8043. PHARMACY TOOK BACK THE MED AND PRIMED AND ATTACHED A NEW THREE PIECE SET. THE NURSE RETURNED A SECOND TIME AND THE SAME SECTION ON THE 1C8043 SET WAS AGAIN BROKEN AND LEAKING WHEN SHE TRIED TO INFUSE DOSE. PHARMACY PRIMED AND ATTACHED NEW 3 PIECE SET IN ORDER FOR PATIENT TO RECEIVE DOSE. THE THIRD SET DID NOT FALL APART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8270045 ↗
• MalfunctionJan 11, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT TWO (2) NITROGLYCERIN SETS CAME APART. IT WAS FURTHER REPORTED THAT THE SETS BROKE WHERE THE TUBING SEGMENT ATTACHES TO THE LUER ACCESS DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8240875 ↗
• MalfunctionJun 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT 'THREE OR FOUR' NITROGLYCERIN SETS HAD SEPARATED. THE ¿TUBING WAS COMING APART¿ WHEN IN USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638882 ↗
• MalfunctionJun 19, 2018Chemical Spillage

  PATIENT RECEIVING CHEMOTHERAPY INFUSION OF TAXOL. TAXOL INFUSION FINISHED. STOPPED THE PUMP AND WENT TO ADMINISTER NEXT CHEMOTHERAPY AGENT OF CARBOPLATIN. AFTER HANGING THE MEDICATION. I SLIPPED ON SOMETHING WET ON THE FLOOR. ORIGINALLY I THOUGHT IT WAS WATER SO I PICKED UP THE LARGE LIQUID SPILL WITH A CHUX PAD. THEN I COULD SMELL A CHEMICAL SMELL. AT THIS TIME THE PATIENT WENT TO GO TO THE BATHROOM, AND SHE WAS WET ALL OVER THE RIGHT SIDE OF HER PANT, AND JACKETS. THE TAXOL HAD LEAKED ON THE PATIENT, AND ON THE FLOOR. APPEARS TO BE SOMETHING WRONG WITH THE TUBING, CAUSING THE CHEMOTHERAPY SPILL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7613311 ↗