Channel Drain 072189Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741049712), received between Jul 18, 2017 and Feb 17, 2026 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (7 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.

• MalfunctionFeb 17, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER BD REPRESENTATIVE HAD A CALL WITH CUSTOMER AND GOT SOME UNFORTUNATE NEWS. AFTER ORDERING MORE OF THE BD DRAINS, END USERS HAVE JUST FOUND MORE OF THIS CONTAMINATE. BD REPRESENTATIVE JUST WENT BACK TO THE SHELVES AND OPENED A NEW PACKAGE AND DID FIND THE WHITE PARTICLES AND HAIRS. PER FOLLOW INFORMATION RECEIVED ON 12FEB2026, BD SALES TEAM WAS ON SITE WITH COREWELL HEALTH TODAY TO DISCUSS THE ISSUE REPORTED ON, RELATED TO FOREIGN MATTER FOUND ON THE WOUND DRAINS. THEY PROVIDED THE SALES TEAM WITH THE IMPACTED LOT, WHICH IS NGKV4053, ASKED TO ENSURE THAT IS ADDED TO THE RECORD. PHOTOS WERE ALSO TAKEN. PER PHOTOS SENT BY BD REPRESENTATIVE, THE FIRST ONE WHERE THE WOUND DRAIN WAS OUT OF THE PACKET APPEARED TO HAVE A FUZZY ON THE OUTSIDE (THIS DOESN¿T REALLY SHOW UP IN THE PICTURE). CUSTOMER HAD THESE SELECTED WHERE IT APPEARED THERE WAS DEBRIS INSIDE THE WOUND DRAIN. THEY COULD NOT REALLY SEE THEM INSIDE THE TUBING, BUT THEY ARE GOING TO SEND TO COVINGTON IN THE RETURN BOX THAT HE WAS GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373252 ↗
• MalfunctionFeb 13, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER BD REPRESENTATIVE HAD A CALL WITH CUSTOMER AND GOT SOME UNFORTUNATE NEWS. AFTER ORDERING MORE OF THE BD DRAINS, END USERS HAVE JUST FOUND MORE OF THIS CONTAMINATE. BD REPRESENTATIVE JUST WENT BACK TO THE SHELVES AND OPENED A NEW PACKAGE AND DID FIND THE WHITE PARTICLES AND HAIRS. PER FOLLOW INFORMATION RECEIVED ON 12FEB2026, BD SALES TEAM WAS ON SITE WITH COREWELL HEALTH TODAY TO DISCUSS THE ISSUE REPORTED, RELATED TO FOREIGN MATTER FOUND ON THE WOUND DRAINS. THEY PROVIDED THE SALES TEAM WITH THE IMPACTED LOT, WHICH IS NGKV4053, ASKED TO ENSURE THAT IS ADDED TO THE RECORD. PHOTOS WERE ALSO TAKEN. PER PHOTOS SENT BY BD REPRESENTATIVE, THE FIRST ONE WHERE THE WOUND DRAIN WAS OUT OF THE PACKET APPEARED TO HAVE A FUZZY ON THE OUTSIDE (THIS DOESN'T REALLY SHOW UP IN THE PICTURE). MICAH HAD THESE SELECTED WHERE IT APPEARED THERE WAS DEBRIS INSIDE THE WOUND DRAIN. THEY COULD NOT REALLY SEE THEM INSIDE THE TUBING, BUT THEY ARE GOING TO SEND TO COVINGTON IN THE RETURN BOX THAT HE WAS GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339223 ↗
• MalfunctionAug 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PATIENT WAS THERE FOR A SURGERY. SURGEON ALWAYS USED TWO 10FR ROUND DRAINS (LOT# NGKP0821). SURGEON OPENED TWO DRAINS AT BEGINNING OF CASE, BOTH DRAINS HAD FUZZY MATERIAL ON THE DRAIN IN THE STERILE PACKAGING. THIS HAS HAPPENED BEFORE. SURGEON SWITCHED AND HAD TO USE 15FR DRAINS WHICH SHOWED NO CONTAMINATION. NO PATIENT HARM WAS REPORTED. NO PHYSICAL SAMPLE WAS AVAILABLE. IT WAS REPORTED THAT PATIENT WAS THERE FOR A SURGERY. SURGEON ALWAYS USED 10FR ROUND DRAINS WITH THIS SURGERY (LOT# NGKP0821). SURGEON 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. SURGEON PROCEEDED TO USE DIFFERENT SIZE DRAIN THAN NEEDED DUE TO THIS ONGOING PROBLEM. NO PATIENT HARM WAS REPORTED. PHYSICAL SAMPLE WAS AVAILABLE. IT WAS REPORTED THAT PHYSICIANS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE (LOT# NGJW3604). WOUND DRAIN HAD DEBRIS, POWDER- LIKE SUBSTANCE ON THEM. VERY OFTEN THE DRAINS HAD SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN. IT WAS SO FREQUENT THAT PHYSICIAN HAD THE STAFF CHECK THE TUBING BEFORE INSER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861550 ↗
• MalfunctionApr 22, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE CONCERN WAS THAT THE TROCAR FOR SILICONE CHANNEL DRAIN WERE INEFFECTIVE IN PENETRATING THE SKIN AND BENDING WHEN TOO MUCH PRESSURE WAS APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881858 ↗
• MalfunctionApr 15, 2025Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED BY THE CUSTOMER THAT HAVING ISSUES WITH THE WOUND DRAINS. PER FOLLOW UP VIA EMAIL RECEIVED ON 02APR2025 STATED THAT THEY WERE STILL HAD ISSUES WITH THE WOUND DRAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21840265 ↗
• MalfunctionFeb 21, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE WOUND DRAIN TUBING KINKED EASILY (PCN#072189, PCN#072231), AND TROCAR WAS DIFFICULT TO INSERT. VERY HARD TO PULL THROUGH THE RUBBER COMPONENT OF THE DRAIN THROUGH THE SKIN, ONE HAD TO PULL SO HARD THIT IT AVULSES THE SKIN FROM THE UNDERLYING TISSUE (PCN#072189, PCN#072231). CUSTOMER TUNNEL THE DRAIN, AND THE TROCAR WAS SO DULL (PCN#072189, PCN#072231) THEY HAD TO EXERT SUCH A LARGE AMOUNT OF FORCE THAT IT BECOME DIFFICULT TO CONTROL, CONCERN THIS MIGHT CAUSE THE TROCAR TO IMPALE OTHER AREAS OF THE PATIENT BODY. TROCAR COULD NOT BE BENT AND CAUSED DISCOMFORT AND INSERTION CHALLENGE CREATED A DELAY IN THE OPERATING ROOM AND COULD EXTEND CASE TIME BY A FEW MINUTES. MADE APPROPRIATE INSERTION OF THE DRAIN IN DIFFICULT IN HARD-TO-REACH PLACES, THIS COULD BE DANGEROUS AS THE TROCAR NEEDED TO BE INSERTED DEEPER AND COULD CAUSE BLEEDING. UNABLE TO SET THE CORRECT ANGLE OF EXIT, ESPECIALLY IN BELOW-KNEE AMPUTATION (PCN#072189, PCN#072231) AND DANGEROUS OR PAINFUL TO PATIENTS AND DIFFICULT TO REMOVE. SEVERAL PATIENTS WERE IN TEARS BECAUSE THE HUBS CAUSED LASTING PAIN ON REMOVAL. DUE TO THE ADDITION OF THE WHITE FLANGE ON THE TUBING, THE BARD CHANNEL DRAINS WERE HARDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21435355 ↗
• MalfunctionFeb 21, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE WOUND DRAIN TUBING KINKED EASILY (PCN#: 072189, PCN#: 072231), AND TROCAR WAS DIFFICULT TO INSERT. VERY HARD TO PULL THROUGH THE RUBBER COMPONENT OF THE DRAIN THROUGH THE SKIN, ONE HAD TO PULL SO HARD THAT IT AVULSES THE SKIN FROM THE UNDERLYING TISSUE (PCN#: 072189, PCN#: 072231). CUSTOMER TUNNEL THE DRAIN, AND THE TROCAR WAS SO DULL (PCN#: 072189, PCN#: 072231) THEY HAD TO EXERT SUCH A LARGE AMOUNT OF FORCE THAT IT BECOME DIFFICULT TO CONTROL, CONCERN THIS MIGHT CAUSE THE TROCAR TO IMPALE OTHER AREAS OF THE PATIENT BODY. TROCAR COULD NOT BE BENT AND CAUSED DISCOMFORT AND INSERTION CHALLENGE CREATED A DELAY IN THE OPERATING ROOM AND COULD EXTEND CASE TIME BY A FEW MINUTES. MADE APPROPRIATE INSERTION OF THE DRAIN IN DIFFICULT IN HARD-TO-REACH PLACES, THIS COULD BE DANGEROUS AS THE TROCAR NEEDED TO BE INSERTED DEEPER AND COULD CAUSE BLEEDING. UNABLE TO SET THE CORRECT ANGLE OF EXIT, ESPECIALLY IN BELOW-KNEE AMPUTATION (PCN#: 072189, PCN#: 072231) AND DANGEROUS OR PAINFUL TO PATIENTS AND DIFFICULT TO REMOVE. SEVERAL PATIENTS WERE IN TEARS BECAUSE THE HUBS CAUSED LASTING PAIN ON REMOVAL. DUE TO THE ADDITION OF THE WHITE FLANGE ON THE TUBING, THE BARD CHANNEL D

  Patient problems: Pain

  MAUDE report 21434316 ↗
• MalfunctionFeb 21, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE WOUND DRAIN TUBING KINKED EASILY (PCN#072189, PCN#072231), AND TROCAR WAS DIFFICULT TO INSERT. VERY HARD TO PULL THROUGH THE RUBBER COMPONENT OF THE DRAIN THROUGH THE SKIN, ONE HAD TO PULL SO HARD THIT IT AVULSES THE SKIN FROM THE UNDERLYING TISSUE (PCN#072189, PCN#072231). CUSTOMER TUNNEL THE DRAIN, AND THE TROCAR WAS SO DULL (PCN#072189, PCN#072231) THEY HAD TO EXERT SUCH A LARGE AMOUNT OF FORCE THAT IT BECOME DIFFICULT TO CONTROL, CONCERN THIS MIGHT CAUSE THE TROCAR TO IMPALE OTHER AREAS OF THE PATIENT BODY. TROCAR COULD NOT BE BENT AND CAUSED DISCOMFORT AND INSERTION CHALLENGE CREATED A DELAY IN THE OPERATING ROOM AND COULD EXTEND CASE TIME BY A FEW MINUTES. MADE APPROPRIATE INSERTION OF THE DRAIN IN DIFFICULT IN HARD-TO-REACH PLACES, THIS COULD BE DANGEROUS AS THE TROCAR NEEDED TO BE INSERTED DEEPER AND COULD CAUSE BLEEDING. UNABLE TO SET THE CORRECT ANGLE OF EXIT, ESPECIALLY IN BELOW-KNEE AMPUTATION (PCN#072189, PCN#072231) AND DANGEROUS OR PAINFUL TO PATIENTS AND DIFFICULT TO REMOVE. SEVERAL PATIENTS WERE IN TEARS BECAUSE THE HUBS CAUSED LASTING PAIN ON REMOVAL. DUE TO THE ADDITION OF THE WHITE FLANGE ON THE TUBING, THE BARD CHANNEL DRAINS WERE HARDE

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

  MAUDE report 21433348 ↗
• MalfunctionFeb 21, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE WOUND DRAIN TUBING KINKED EASILY (PCN#072189, PCN#072231), AND TROCAR WAS DIFFICULT TO INSERT. VERY HARD TO PULL THROUGH THE RUBBER COMPONENT OF THE DRAIN THROUGH THE SKIN, ONE HAD TO PULL SO HARD THIT IT AVULSES THE SKIN FROM THE UNDERLYING TISSUE (PCN#072189, PCN#072231). CUSTOMER TUNNEL THE DRAIN, AND THE TROCAR WAS SO DULL (PCN#072189, PCN#072231) THEY HAD TO EXERT SUCH A LARGE AMOUNT OF FORCE THAT IT BECOME DIFFICULT TO CONTROL, CONCERN THIS MIGHT CAUSE THE TROCAR TO IMPALE OTHER AREAS OF THE PATIENT BODY. TROCAR COULD NOT BE BENT AND CAUSED DISCOMFORT AND INSERTION CHALLENGE CREATED A DELAY IN THE OPERATING ROOM AND COULD EXTEND CASE TIME BY A FEW MINUTES. MADE APPROPRIATE INSERTION OF THE DRAIN IN DIFFICULT IN HARD-TO-REACH PLACES, THIS COULD BE DANGEROUS AS THE TROCAR NEEDED TO BE INSERTED DEEPER AND COULD CAUSE BLEEDING. UNABLE TO SET THE CORRECT ANGLE OF EXIT, ESPECIALLY IN BELOW-KNEE AMPUTATION (PCN#072189, PCN#072231) AND DANGEROUS OR PAINFUL TO PATIENTS AND DIFFICULT TO REMOVE. SEVERAL PATIENTS WERE IN TEARS BECAUSE THE HUBS CAUSED LASTING PAIN ON REMOVAL. DUE TO THE ADDITION OF THE WHITE FLANGE ON THE TUBING, THE BARD CHANNEL DRAINS WERE HARDE

  Patient problems: Discomfort

  MAUDE report 21432952 ↗
• MalfunctionFeb 14, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THEY WERE RECEIVED COMPLAINTS ABOUT TROCAR DRAINS. THE CONNECTION WAS BULKY (CIRCLED IN BLACK) AND REQUIRES A LARGER INCISION. THESE DRAINS WERE TRAILED BEFORE THEY CONVERTED AND AT THE TIME OF TRIAL THAT WAS NOT THE CASE. SEEMS LIKE IT WAS RECENTLY CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21383730 ↗
• InjurySep 4, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE WOUND DRAIN WAS IN THE PATIENT AND THERE WAS ZERO SUCTION AND WOULD NOT HOLD SUCTION EVEN AFTER FLUSHING IT. THEY OPENED PATIENT BACK UP AND PLACED A NEW DRAIN. DOCTORS HAD ATTACHED STAFF IN ROOM. THEY HAD DIRTY DRAIN STILL IN OFFICE IF NEEDED. THEY HAD TO RE-ENTER PATIENT TO REPLACE DRAIN.

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

  MAUDE report 20134372 ↗
• InjuryDec 7, 2023Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PLASTIC SURGERY DEPARTMENT IN SEATTLE WAS HAVING TROUBLE WITH THE DRAINS WITH SHARPNESS OF THE TROCARS. THEIR NEED WAS URGENT AS THEY HAD INJURIES USING THE PRODUCT. THE PLASTIC SURGEONS REFUSED TO USE THEM BECAUSE THEY WERE ¿NOT SAFE¿. THEY GAVE LITTLE MORE INFORMATION ABOUT THE DEFECTIVE TROCARS. THE EVENT WAS REPORTED ON (B)(6) 2023, SURGICAL DRAIN PROVIDED FOR THE CASE WAS A BARD 15 FRENCH FULLY FLUTED AROUND DRAIN ON A TROCAR. IT WAS VERY DULL TROCAR, WHICH DID NOT PASS THROUGH THE SKIN CREATING A DANGEROUS SITUATION. THE AMOUNT OF FORCE REQUIRED TO PUSH THIS TO SKIN WAS TOO GREAT TO CONTINUE SO THEY USED ANOTHER KNIFE WAS NEEDED TO CUT THE SKIN. THE EVENT WAS REPORTED ON (B)(6) 2023, 15 FRENCH ROUND FLUTED DRAIN WITH TROCAR PROVIDED INTRAOPERATIVELY, BUT THE WRONG MANUFACTURER BARD DRAIN WAS PROVIDED, DESIRED DRAIN IN CARDINAL DRAIN. THEY PLACED THE TROCARS THROUGH THE SKIN WITH DIFFICULTY, AND ON ONE SIDE, WITH THE TROCAR ALREADY PASSED THROUGH A LONG SUBCUTANEOUS TUNNEL AND PARTED WAY THROUGH THE SKIN WOULD GO NO FURTHER, REQUIRED SCALPEL TO CUT THE SKIN AROUND THE DRAIN TO ALLOW IT TO PASS THROUGH. HIGH RISK OF SHARPS INJURY WITH THE BARD DRAIN. TH

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18282050 ↗
• InjuryDec 5, 2023Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PLASTIC SURGERY DEPARTMENT IN SEATTLE WAS HAVING TROUBLE WITH THE DRAINS WITH SHARPNESS OF THE TROCARS. THEIR NEED WAS URGENT AS THEY HAD INJURIES USING THE PRODUCT. THE PLASTIC SURGEONS REFUSED TO USE THEM BECAUSE THEY WERE ¿NOT SAFE¿. THEY GAVE LITTLE MORE INFORMATION ABOUT THE DEFECTIVE TROCARS. THE EVENT WAS REPORTED ON 20OCT2023, SURGICAL DRAIN PROVIDED FOR THE CASE WAS A BARD 15 FRENCH FULLY FLUTED AROUND DRAIN ON A TROCAR. IT WAS VERY DULL TROCAR, WHICH DID NOT PASS THROUGH THE SKIN CREATING A DANGEROUS SITUATION. THE AMOUNT OF FORCE REQUIRED TO PUSH THIS TO SKIN WAS TOO GREAT TO CONTINUE SO THEY USED ANOTHER KNIFE WAS NEEDED TO CUT THE SKIN. THE EVENT WAS REPORTED ON 01NOV2023, 15 FRENCH ROUND FLUTED DRAIN WITH TROCAR PROVIDED INTRAOPERATIVELY, BUT THE WRONG MANUFACTURER BARD DRAIN WAS PROVIDED, DESIRED DRAIN IN CARDINAL DRAIN. THEY PLACED THE TROCARS THROUGH THE SKIN WITH DIFFICULTY, AND ON ONE SIDE, WITH THE TROCAR ALREADY PASSED THROUGH A LONG SUBCUTANEOUS TUNNEL AND PARTED WAY THROUGH THE SKIN WOULD GO NO FURTHER, REQUIRED SCALPEL TO CUT THE SKIN AROUND THE DRAIN TO ALLOW IT TO PASS THROUGH. HIGH RISK OF SHARPS INJURY WITH THE BARD DRAIN. THIS W

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18265641 ↗
• InjuryDec 4, 2023Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PLASTIC SURGERY DEPARTMENT IN SEATTLE WAS HAVING TROUBLE WITH THE DRAINS WITH SHARPNESS OF THE TROCARS. THEIR NEED WAS URGENT AS THEY HAD INJURIES USING THE PRODUCT. THE PLASTIC SURGEONS REFUSED TO USE THEM BECAUSE THEY WERE ¿NOT SAFE¿. THEY GAVE LITTLE MORE INFORMATION ABOUT THE DEFECTIVE TROCARS. THE EVENT WAS REPORTED ON 20OCT2023, SURGICAL DRAIN PROVIDED FOR THE CASE WAS A BARD 15 FRENCH FULLY FLUTED AROUND DRAIN ON A TROCAR. IT WAS VERY DULL TROCAR, WHICH DID NOT PASS THROUGH THE SKIN CREATING A DANGEROUS SITUATION. THE AMOUNT OF FORCE REQUIRED TO PUSH THIS TO SKIN WAS TOO GREAT TO CONTINUE SO THEY USED ANOTHER KNIFE WAS NEEDED TO CUT THE SKIN. THE EVENT WAS REPORTED ON 01NOV2023, 15 FRENCH ROUND FLUTED DRAIN WITH TROCAR PROVIDED INTRAOPERATIVELY, BUT THE WRONG MANUFACTURER BARD DRAIN WAS PROVIDED, DESIRED DRAIN IN CARDINAL DRAIN. THEY PLACED THE TROCARS THROUGH THE SKIN WITH DIFFICULTY, AND ON ONE SIDE, WITH THE TROCAR ALREADY PASSED THROUGH A LONG SUBCUTANEOUS TUNNEL AND PARTED WAY THROUGH THE SKIN WOULD GO NO FURTHER, REQUIRED SCALPEL TO CUT THE SKIN AROUND THE DRAIN TO ALLOW IT TO PASS THROUGH. HIGH RISK OF SHARPS INJURY WITH THE BARD DRAIN. THIS W

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18258716 ↗
• MalfunctionJul 14, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE WOUND DRAIN WAS AN EMPTY PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324315 ↗
• MalfunctionJan 23, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR WAS FOUND IN THE WOUND DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225711 ↗
• MalfunctionOct 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A STRAIN OF HAIR THAT CAME SEALED IN THE WOUND DRAIN PACKAGE. IT WAS STATED THAT THIS PRODUCT WAS SUPPOSED TO COME STERILIZED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2022, THERE WAS NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536261 ↗
• MalfunctionMar 4, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE EDGE OF THE SILICONE DRAIN WAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666778 ↗
• MalfunctionFeb 28, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SILICONE CHANNEL DRAIN EDGE WAS BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621038 ↗
• MalfunctionNov 4, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE DRAIN WAS DULL SO THAT THE SURGEON ARE UNABLE TO INSERT THE BLAKE DRAIN WITHOUT MAKING AN INCISION. PER ADDITION INFORMATION VIA EMAIL ON 13OCT2020, SAME ISSUE. NO, THEY ARE USING THE DRAINS BUT STRUGGLING TO GET THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10785844 ↗
• MalfunctionOct 27, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE DRAIN WAS DULL SO THAT THE SURGEON WAS UNABLE TO INSERT THE BLAKE DRAIN WITHOUT MAKING AN INCISION NGER2802 PER ADDITION INFORMATION VIA EMAIL ON 13 OCT 2020, SAME ISSUE. NO, THEY WERE USING THE DRAINS BUT STRUGGLED TO GET THEM IN NGER0489.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10744917 ↗
• InjuryJan 22, 2018Break; Physical Resistance

  IT WAS REPORTED THAT A PATIENT WAS ADMITTED WITH POST MOTOR VEHICLE ACCIDENT WITH MULTIPLE TRAUMA INCLUDING A LACERATED LIVER AND SPLEEN. DRAINS WERE PLACED DURING SURGERY. WHEN A NURSE ATTEMPTED TO REMOVE ONE OF THE DRAINS, IT BROKE AND WAS RETAINED INSIDE THE PATIENT. THE PATIENT WAS SENT TO THE OPERATING ROOM TO HAVE THE PIECE SURGICALLY REMOVED. THE REMAINING PART WAS REMOVED WITHOUT COMPLICATION. IT WAS LATER REPORTED THAT ON (B)(6) 2017, THE PATIENT HAD OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF LEFT RIBS, EVACUATION OF RETAINED HEMOTHORAX (HTX) AND EFFUSION, A LEFT CT WAS DONE AND DRAINS WERE PLACED. ON (B)(6) 2017, THERE WAS AN ORDER FOR THE BULB DRAINS TO BE REMOVED. WHEN THE NURSE PULLED, SHE THOUGHT THE END CAME OFF OF ONE OF THE DRAINS. THE NURSE FELT RESISTANCE, AND THE PATIENT WAS (B)(6). ON PHYSICAL EXAM, THE NURSE WAS UNABLE TO PALPATE THE DRAIN. A HEMOSTAT WAS USED AND THE DISTAL PORTION OF THE DRAIN WAS NOT ABLE TO BE FELT. A CHEST X-RAY AND CT OF THE CHEST WAS DONE. ON (B)(6) 2017 SURGERY WAS DONE TO REMOVE THE RETAINED PORTION OF THE DRAIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7209637 ↗
• MalfunctionJul 18, 2017Sticking

  IT WAS REPORTED THAT THE CHANNEL DRAIN WAS CATCHING ON THE PATIENT DURING REMOVAL; THEREFORE, THE PATIENT EXPERIENCED PAIN DURING THE REMOVAL OF THE CHANNEL DRAIN.

  Patient problems: Pain

  MAUDE report 6723336 ↗