Channel Drain V072229Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741119194), received between Sep 22, 2021 and Sep 15, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (14 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Wrong Label

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781989 ↗
• MalfunctionSep 15, 2026Wrong Label

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781537 ↗
• MalfunctionFeb 19, 2026Complete Blockage

  IT WAS REPORTED THAT THE WOUND DRAIN WAS THE V072229 15 FR ROUND WITH TROCAR. TROCAR WAS TOO DULL, WOULD NOT PIERCE THE SKIN, FEEL LIKE THEY GOING TO HURT THEMSELVES TRIED TO PUSH THAT THROUGH THE SKIN. THE TUBING WAS VERY FLIMSY WHEN PLUGGED IT INTO THE BULB, THAT WOULD KINK AT THE INSERTION SITE AND THE BULB WAS SLOWLY INFLATING ITSELF THAT WAS THE MESSAGE CAME FROM THE FLOOR TO THE PA¿S/RNFA THAT HAD PATIENTS ON THE FLOOR. WHEN CLAMPED TO THE BED TO PREVENT THAT FROM FELL OFF, FEEL THERE ARE MICRO PUNCTURES IN THAT AND WOULD NOT ALLOW THE BULB TO STAY INFLATED, PLASTIC WAS TOO FRAGILE THEY WERE ONLY CLAMPING THE TUBE TO THE BED AT THE END OF THE TUBE, NOT IN THE MIDDLE THEY TRIED CUTTING OFF THE PART THAT WAS CLAMPED AND THAT HAD NOT MADE ANY DIFFERENCE IN THE BULB SLOWLY INFLATING WITH AIR, NOT FLUID FROM THE SITE. THE FIT OF THE TUBING TO THE BULB WAS VERY LOOSE. IN THE OFFICE WHEN DRAINS ARE PULLED, SAW CLOT COME OUT AT THE END OF THE DRAIN. THEIR OFFICE HAD SEEN MORE SEROMAS SINCE THEY HAD STARTED USING THAT DRAIN. THAT WAS FROM 2 PLASTIC SURGERY OFFICES THAT USE A LOT OF DRAINS. HAD THE OTHER COMPLAINTS ABOUT THAT DRAIN IN PARTICULAR? WAS THERE ROOM FOR CARVE OUT TO BRING B

  Patient problems: Seroma

  MAUDE report 24388962 ↗
• MalfunctionFeb 18, 2026Dull, Blunt

  IT WAS REPORTED THAT THE WOUND DRAIN WAS THE V072229 15 FR ROUND WITH TROCAR. TROCAR WAS TOO DULL, WOULD NOT PIERCE THE SKIN, FEEL LIKE THEY GOING TO HURT THEMSELVES TRIED TO PUSH THAT THROUGH THE SKIN. THE TUBING WAS VERY FLIMSY WHEN PLUGGED IT INTO THE BULB, THAT WOULD KINK AT THE INSERTION SITE AND THE BULB WAS SLOWLY INFLATING ITSELF THAT WAS THE MESSAGE CAME FROM THE FLOOR TO THE PA¿S/RNFA THAT HAD PATIENTS ON THE FLOOR. WHEN CLAMPED TO THE BED TO PREVENT THAT FROM FELL OFF, FEEL THERE ARE MICRO PUNCTURES IN THAT AND WOULD NOT ALLOW THE BULB TO STAY INFLATED, PLASTIC WAS TOO FRAGILE THEY WERE ONLY CLAMPING THE TUBE TO THE BED AT THE END OF THE TUBE, NOT IN THE MIDDLE THEY TRIED CUTTING OFF THE PART THAT WAS CLAMPED AND THAT HAD NOT MADE ANY DIFFERENCE IN THE BULB SLOWLY INFLATING WITH AIR, NOT FLUID FROM THE SITE. THE FIT OF THE TUBING TO THE BULB WAS VERY LOOSE. IN THE OFFICE WHEN DRAINS ARE PULLED, SAW CLOT COME OUT AT THE END OF THE DRAIN. THEIR OFFICE HAD SEEN MORE SEROMAS SINCE THEY HAD STARTED USING THAT DRAIN. THAT WAS FROM 2 PLASTIC SURGERY OFFICES THAT USE A LOT OF DRAINS. HAD THEY OTHER COMPLAINTS ABOUT THAT DRAIN IN PARTICULAR? WAS THERE ROOM FOR CARVE OUT TO BRING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383907 ↗
• MalfunctionFeb 18, 2026Fitting Problem

  IT WAS REPORTED THAT THE WOUND DRAIN WAS THE V072229 15 FR ROUND WITH TROCAR. TROCAR WAS TOO DULL, WOULD NOT PIERCE THE SKIN, FEEL LIKE THEY GOING TO HURT THEMSELVES TRIED TO PUSH THAT THROUGH THE SKIN. THE TUBING WAS VERY FLIMSY WHEN PLUGGED IT INTO THE BULB, THAT WOULD KINK AT THE INSERTION SITE AND THE BULB WAS SLOWLY INFLATING ITSELF THAT WAS THE MESSAGE CAME FROM THE FLOOR TO THE PA¿S/RNFA THAT HAD PATIENTS ON THE FLOOR. WHEN CLAMPED TO THE BED TO PREVENT THAT FROM FELL OFF, FEEL THERE ARE MICRO PUNCTURES IN THAT AND WOULD NOT ALLOW THE BULB TO STAY INFLATED, PLASTIC WAS TOO FRAGILE THEY WERE ONLY CLAMPING THE TUBE TO THE BED AT THE END OF THE TUBE, NOT IN THE MIDDLE THEY TRIED CUTTING OFF THE PART THAT WAS CLAMPED AND THAT HAD NOT MADE ANY DIFFERENCE IN THE BULB SLOWLY INFLATING WITH AIR, NOT FLUID FROM THE SITE. THE FIT OF THE TUBING TO THE BULB WAS VERY LOOSE. IN THE OFFICE WHEN DRAINS ARE PULLED, SAW CLOT COME OUT AT THE END OF THE DRAIN. THEIR OFFICE HAD SEEN MORE SEROMAS SINCE THEY HAD STARTED USING THAT DRAIN. THAT WAS FROM 2 PLASTIC SURGERY OFFICES THAT USE A LOT OF DRAINS. HAD THEY OTHER COMPLAINTS ABOUT THAT DRAIN IN PARTICULAR? WAS THERE ROOM FOR CARVE OUT TO BRING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383900 ↗
• MalfunctionFeb 18, 2026Material Too Soft/Flexible

  IT WAS REPORTED THAT THE WOUND DRAIN WAS THE V072229 15 FR ROUND WITH TROCAR. TROCAR WAS TOO DULL, WOULD NOT PIERCE THE SKIN, FEEL LIKE THEY GOING TO HURT THEMSELVES TRIED TO PUSH THAT THROUGH THE SKIN. THE TUBING WAS VERY FLIMSY WHEN PLUGGED IT INTO THE BULB, THAT WOULD KINK AT THE INSERTION SITE AND THE BULB WAS SLOWLY INFLATING ITSELF THAT WAS THE MESSAGE CAME FROM THE FLOOR TO THE PA¿S/RNFA THAT HAD PATIENTS ON THE FLOOR. WHEN CLAMPED TO THE BED TO PREVENT THAT FROM FELL OFF, FEEL THERE ARE MICRO PUNCTURES IN THAT AND WOULD NOT ALLOW THE BULB TO STAY INFLATED, PLASTIC WAS TOO FRAGILE THEY WERE ONLY CLAMPING THE TUBE TO THE BED AT THE END OF THE TUBE, NOT IN THE MIDDLE THEY TRIED CUTTING OFF THE PART THAT WAS CLAMPED AND THAT HAD NOT MADE ANY DIFFERENCE IN THE BULB SLOWLY INFLATING WITH AIR, NOT FLUID FROM THE SITE. THE FIT OF THE TUBING TO THE BULB WAS VERY LOOSE. IN THE OFFICE WHEN DRAINS ARE PULLED, SAW CLOT COME OUT AT THE END OF THE DRAIN. THEIR OFFICE HAD SEEN MORE SEROMAS SINCE THEY HAD STARTED USING THAT DRAIN. THAT WAS FROM 2 PLASTIC SURGERY OFFICES THAT USE A LOT OF DRAINS. HAD THEY OTHER COMPLAINTS ABOUT THAT DRAIN IN PARTICULAR? WAS THERE ROOM FOR CARVE OUT TO BRIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383219 ↗
• MalfunctionFeb 18, 2026Decrease in Suction

  IT WAS REPORTED THAT THE WOUND DRAIN WAS THE V072229 15 FR ROUND WITH TROCAR. TROCAR WAS TOO DULL, WOULD NOT PIERCE THE SKIN, FEEL LIKE THEY GOING TO HURT THEMSELVES TRIED TO PUSH THAT THROUGH THE SKIN. THE TUBING WAS VERY FLIMSY WHEN PLUGGED IT INTO THE BULB, THAT WOULD KINK AT THE INSERTION SITE AND THE BULB WAS SLOWLY INFLATING ITSELF THAT WAS THE MESSAGE CAME FROM THE FLOOR TO THE PA¿S/RNFA THAT HAD PATIENTS ON THE FLOOR. WHEN CLAMPED TO THE BED TO PREVENT THAT FROM FELL OFF, FEEL THERE ARE MICRO PUNCTURES IN THAT AND WOULD NOT ALLOW THE BULB TO STAY INFLATED PLASTIC WAS TOO FRAGILE THEY WERE ONLY CLAMPING THE TUBE TO THE BED AT THE END OF THE TUBE, NOT IN THE MIDDLE THEY TRIED CUTTING OFF THE PART THAT WAS CLAMPED AND THAT HAD NOT MADE ANY DIFFERENCE IN THE BULB SLOWLY INFLATING WITH AIR, NOT FLUID FROM THE SITE. THE FIT OF THE TUBING TO THE BULB WAS VERY LOOSE. IN THE OFFICE WHEN DRAINS ARE PULLED, SAW CLOT COME OUT AT THE END OF THE DRAIN. THEIR OFFICE HAD SEEN MORE SEROMAS SINCE THEY HAD STARTED USING THAT DRAIN. THAT WAS FROM 2 PLASTIC SURGERY OFFICES THAT USE A LOT OF DRAINS. HAD THEY OTHER COMPLAINTS ABOUT THAT DRAIN IN PARTICULAR? WAS THERE ROOM FOR CARVE OUT TO BRING B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383064 ↗
• MalfunctionAug 22, 2025Defective Device; Wrong Label; Defective Device; Wrong Label

  IT WAS REPORTED THAT ISSUE FIRST IDENTIFIED IN FEBRUARY: WE DISCOVERED THAT SOME DRAINS LABELED AS 19F WERE ACTUALLY 15F (LOT # NGJV0169). DISTRIBUTION AND LOGISTICS TEAM STARTED CHECKING LOT NUMBERS ON ALL INCOMING SHIPMENTS RIGHT AWAY AND 227 DRAINS WERE REMOVED FROM INVENTORY. BD WAS NOTIFIED AND SAMPLES OF THE AFFECTED DRAINS WERE SENT BACK TO PRODUCT ANALYSIS. CLOSURE LETTER RECEIVED: BD CONFIRMED THE MISLABELING AND SENT A CLOSURE LETTER IN JUNE. AT THAT TIME THERE WERE NO ADDITIONAL COMPLAINTS SUBMITTED FOR MISLABELED DRAINS. THE PRODUCT COMPLAINT WAS CLOSED OUT. NEW DRAINS FOUND RECENTLY AND CUSTOMER SUBMITTED A PRODUCT COMPLAINT ON 7/23/25 FOR 10 ADDITIONAL DRAINS THAT WERE FOUND WITH THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874532 ↗
• MalfunctionMar 24, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE WOUND DRAIN WAS LABELED AS 19FR AND THE ACTUAL DRAIN IN PACKAGING WAS A 15FR DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676378 ↗
• MalfunctionMar 21, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE DRAIN WAS LABELED AS 19FR AND THE ACTUAL DRAIN IN PACKAGING WAS A 15FR DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663201 ↗
• MalfunctionMar 21, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT WOUND DRAIN LABELED AS 19FR DRAIN. ACTUAL DRAIN IN PACKAGING WAS A 15FR DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663195 ↗
• MalfunctionMar 21, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE WOUND DRAIN WHEN OPENED WAS LABELED AS 19FR AND THE ACTUAL DRAIN IN PACKAGING WAS A 15FR DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663190 ↗
• MalfunctionMar 3, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE WOUND DRAIN PACKAGE WAS LABELED AS 19FR DRAIN AND THE ACTUAL DRAIN IN PACKAGING WAS A 15FR DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503692 ↗
• MalfunctionFeb 27, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT 19FR WOUND DRAIN PACKAGE CONTAINS 15FR DRAIN. THIS WAS A PATIENT SAFETY CONCERN BECAUSE IF SURGEON DID NOT NOTICE AND USED THIS SIZE EXPECTING A LARGER ONE, THE PATIENT WOULD NOT HAVE THE PROPER DRAINAGE THEY NEEDED. THIS COULD BE DETRIMENTAL TO THE PATIENT¿S RECOVERY. THE CONTACT REMOVED ANY THEY COULD FIND ON THE SHELF AND SENT WORD TO SUPPLY TO REMOVE FROM OTHER LOCATIONS. IT WAS NOTED THAT THE GIVEN LOT# WAS NGJV0169.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21479857 ↗
• MalfunctionFeb 25, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE FACILITY WANTED TO RETURN 227 PACKAGES OF WOUND DRAIN, WHICH CAME IN THE WRONG SIZE. THE LABEL READS 19 FR, BUT THEY WERE ACTUALLY 15 FR. THE CUSTOMER WAS TRYING TO FIGURE OUT WHAT TO DO WITH THIS DEFECTIVE PRODUCT. THIS WAS SENT OVER TO CLAIMS TO ISSUE AN RMA NUMBER FOR RETURN WHEN IT SHOULD HAVE GONE OVER TO THE PRODUCT COMPLAINTS TEAM IF THERE WAS A PACKAGING OR LABELING COMPLAINT. PER CUSTOMER VIA EMAIL ON 04MAR2025, IT WAS REPORTED THAT 227 PACKAGES LABELED 19F, BUT TUBING WAS ACTUALLY 15F. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459291 ↗
• MalfunctionJan 24, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE WOUND DRAIN THAT WAS PACKAGED IN THE 19FR PACKAGING WAS SMALL THAN IT SHOULD BE. THEY COMPARED TWO WOUND DRAINS BOTH PACKAGED AS 19FR DRAINS AND THE ONE ON THE LEFT WAS SMALLER THAN THE ONE ON THE RIGHT. PER ADDITIONAL RECEIVED ON 14JAN2025, IT WAS REPORTED THAT THEY PROVIDED LOT#NGJV0169. A SURGEON WAS GIVEN THE 19FR WOUND DRAIN. AFTER TAKING IT OUT OF THE PACKAGING IN THE STERILE FIELD THE SURGEON NOTICED THAT IT WAS NOT THE CORRECT SIZE. THEY HAD TO LEAVE THE STERILE FIELD IN ORDER TO GO AND LOOK THROUGH THE DRAINS TO FIND THE CORRECT SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231514 ↗
• MalfunctionJan 8, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE NOVAPLUSCHANNELDRAIN CAME PACKAGED WITH 15F DRAINS RATHER THAN 19F. PER FOLLOW UP VIA PHONE ON 03JAN2025.THE PRODUCT WAS PACKAGED AS V072231 BUT THE PRODUCT INSIDE WAS V072229. IT WAS USED ON THE PATIENT AND ONCE THEY REALIZED IT WAS THE INCORRECT SIZE, IT WAS REMOVED IMMEDIATELY. NO PATIENT HARM WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102439 ↗
• MalfunctionDec 2, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE CUSTOMER WAS USING A 19 FR WOUND DRAIN AND HAD TO PULL THEM FROM CASES BECAUSE THE PACKAGE CONTAINED A 15 FR DRAIN INSTEAD. THE STAFF PULLED TEN OF THESE DRAINS FROM THE BIN. THE PACKAGING WAS SAYING 19FR, BUT THE DRAIN WAS A 15FR SIZE. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON (B)(6) 2024, STATED THAT THERE WAS NO MEDICAL INTERVENTION REPORTED AND THE DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818451 ↗
• MalfunctionNov 26, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER RECEIVED A DIFFERENT SIZED WOUND DRAIN IN PACKAGING. THEY HAD 15FR DRAINS THAT WERE LABELLED AS 19FR DRAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785142 ↗
• MalfunctionNov 15, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE CUSTOMER HAD TWO SEPARATE POS- PO:4517838642 & PO 4517885835 WHERE THEY HAD RECEIVED THE WRONG PRODUCT. THE BOX WAS MARKED CHANNEL DRAIN 15FR ROUND HUBLESS FULL FLUTED SILICONE WITH 4.7MM TROCAR, BUT THE BOXES ACTUALLY CONTAINED 19FR DRAINS, AND THEY NOW HAD 7 PLUS CASES OF 19FR DRAINS AND NO 15FR DRAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694343 ↗
• MalfunctionMay 30, 2023Suction Failure; Suction Failure

  IT WAS REPORTED THAT CUSTOMER HAD SOME ISSUES THEY HAD BEEN EXPERIENCING WITH WOUND DRAIN. IN SHORT, THERE WAS SOME INCIDENTS WHERE THE SUCTION OF THE DRAIN BULB HAD EITHER BEEN SUBPAR OR HAD FAILED. THROUGH INTERNAL DISCUSSIONS, IT HAD BEEN DETERMINED THAT IT WAS POSSIBLE THAT THE MINISTRY RECEIVED A DEFECTIVE BATCH, AND THEY WERE CURRENTLY WORKING TO HAVE THOSE DRAINS REPLACED, BUT UNFORTUNATELY HAVE BEEN TOLD THAT THESE HAVE BEEN PLACED ON AN INDEFINITE BACKORDER. THIS OF COURSE POSES A PROBLEM, BECAUSE IT NOT ONLY CONTINUES TO IMPEDE SSM ABILITY TO COMPLETE THE CONVERSION THAT THEY BEEN WORKING TOWARDS, BUT NOW ALSO IMPACTS PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17024566 ↗
• MalfunctionMay 11, 2023Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES WITH ONE OF THE DRAINS THEY USED. CUSTOMER HAD SIX DRAINS FAILED ON THEM OVER THE PAST 3 MONTHS AND ALSO STATED THE TROCAR WAS NOT AS SHARP AND EASY TO USE AS ONES THEY USED IN THE PAST .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911886 ↗
• MalfunctionSep 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A CLEAR SUBSTANCE ON THE TROCAR AND WAS ISOLATED ONCE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514200 ↗