Channel Drain 072188Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741049705), received between Dec 11, 2019 and Jun 24, 2025 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT SEVERAL CONCERNS REGARDING THE CURRENT DRAIN SETUP. PATIENTS WERE EXPERIENCING SIGNIFICANT DISCOMFORT DURING REMOVAL, WHICH HAD BEEN DESCRIBED AS PAINFUL. ADDITIONALLY, THE FLANGES TEND TO STRETCH THE DRAIN WHEN MANIPULATED, INCREASING THE RISK OF THE DRAIN DETACHING UNINTENTIONALLY. THESE ISSUES NOT ONLY IMPACT PATIENT COMFORT BUT ALSO RAISE POTENTIAL SAFETY CONCERNS THAT NEED TO BE ADDRESSED PROMPTLY. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28MAY2025, THE FLANGE ON THE DRAIN CURLS UP ON ITSELF WHEN IT WAS STRETCHED. THEN THEY TUGGED ON IT TO DEMONSTRATE, IT BROKE INTO 2 PIECES. THE OTHER 15 ROUND CHANNEL BLAKE HUB LESS DRAIN BROUGHT FROM GMH TO PMH FOR THEM TO TRY WAS TOO FLIMSY, KINKS ON ITSELF SO IT DID NOT DRAIN, AND DID NOT HAD A LONG ENOUGH OR FIRM ENOUGH AREA TO SECURE IT WITH SUTURE. THEY USED THEM YESTERDAY HAD A VERY DIFFICULT TIME TYING THE SECURING STITCH TIGHT ENOUGH TO HOLD IT WITHOUT CRIMPING THE DRAIN AND PREVENTING DRAIN FUNCTION. THE AREA WHERE IT WAS SUPPOSED TO BE SECURED WAS PROXIMAL TO THE BLACK DOT AND YET WAS SO SHORT THAT MINOR MOVEMENTS IN THE DRAIN WOULD CAUSE THE CHANNELS TO BE IN THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321981 ↗
• MalfunctionJun 24, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT SEVERAL CONCERNS REGARDING THE CURRENT DRAIN SETUP. PATIENTS WERE EXPERIENCING SIGNIFICANT DISCOMFORT DURING REMOVAL, WHICH HAD BEEN DESCRIBED AS PAINFUL. ADDITIONALLY, THE FLANGES TEND TO STRETCH THE DRAIN WHEN MANIPULATED, INCREASING THE RISK OF THE DRAIN DETACHING UNINTENTIONALLY. THESE ISSUES NOT ONLY IMPACT PATIENT COMFORT BUT ALSO RAISE POTENTIAL SAFETY CONCERNS THAT NEED TO BE ADDRESSED PROMPTLY. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28MAY2025, THE FLANGE ON THE DRAIN CURLS UP ON ITSELF WHEN IT WAS STRETCHED. THEN THEY TUGGED ON IT TO DEMONSTRATE, IT BROKE INTO 2 PIECES. THE OTHER 15 ROUND CHANNEL BLAKE HUB LESS DRAIN BROUGHT FROM GMH TO PMH FOR THEM TO TRY WAS TOO FLIMSY, KINKS ON ITSELF SO IT DID NOT DRAIN, AND DID NOT HAD A LONG ENOUGH OR FIRM ENOUGH AREA TO SECURE IT WITH SUTURE. THEY USED THEM YESTERDAY HAD A VERY DIFFICULT TIME TYING THE SECURING STITCH TIGHT ENOUGH TO HOLD IT WITHOUT CRIMPING THE DRAIN AND PREVENTING DRAIN FUNCTION. THE AREA WHERE IT WAS SUPPOSED TO BE SECURED WAS PROXIMAL TO THE BLACK DOT AND YET WAS SO SHORT THAT MINOR MOVEMENTS IN THE DRAIN WOULD CAUSE THE CHANNELS TO BE IN THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320640 ↗
• MalfunctionJun 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SEVERAL CONCERNS REGARDING THE CURRENT DRAIN SETUP. PATIENTS WERE EXPERIENCING SIGNIFICANT DISCOMFORT DURING REMOVAL, WHICH HAD BEEN DESCRIBED AS PAINFUL. ADDITIONALLY, THE FLANGES TEND TO STRETCH THE DRAIN WHEN MANIPULATED, INCREASING THE RISK OF THE DRAIN DETACHING UNINTENTIONALLY. THESE ISSUES NOT ONLY IMPACT PATIENT COMFORT BUT ALSO RAISE POTENTIAL SAFETY CONCERNS THAT NEED TO BE ADDRESSED PROMPTLY. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28MAY2025, THE FLANGE ON THE DRAIN CURLS UP ON ITSELF WHEN IT WAS STRETCHED. THEN THEY TUGGED ON IT TO DEMONSTRATE, IT BROKE INTO 2 PIECES. THE OTHER 15 ROUND CHANNEL BLAKE HUB LESS DRAIN BROUGHT FROM GMH TO PMH FOR THEM TO TRY WAS TOO FLIMSY, KINKS ON ITSELF SO IT DID NOT DRAIN, AND DID NOT HAD A LONG ENOUGH OR FIRM ENOUGH AREA TO SECURE IT WITH SUTURE. THEY USED THEM YESTERDAY HAD A VERY DIFFICULT TIME TYING THE SECURING STITCH TIGHT ENOUGH TO HOLD IT WITHOUT CRIMPING THE DRAIN AND PREVENTING DRAIN FUNCTION. THE AREA WHERE IT WAS SUPPOSED TO BE SECURED WAS PROXIMAL TO THE BLACK DOT AND YET WAS SO SHORT THAT MINOR MOVEMENTS IN THE DRAIN WOULD CAUSE THE CHANNELS TO BE IN THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319837 ↗
• MalfunctionJun 24, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT SEVERAL CONCERNS REGARDING THE CURRENT DRAIN SETUP. PATIENTS WERE EXPERIENCING SIGNIFICANT DISCOMFORT DURING REMOVAL, WHICH HAD BEEN DESCRIBED AS PAINFUL. ADDITIONALLY, THE FLANGES TEND TO STRETCH THE DRAIN WHEN MANIPULATED, INCREASING THE RISK OF THE DRAIN DETACHING UNINTENTIONALLY. THESE ISSUES NOT ONLY IMPACT PATIENT COMFORT BUT ALSO RAISE POTENTIAL SAFETY CONCERNS THAT NEED TO BE ADDRESSED PROMPTLY. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28MAY2025, THE FLANGE ON THE DRAIN CURLS UP ON ITSELF WHEN IT WAS STRETCHED. THEN THEY TUGGED ON IT TO DEMONSTRATE, IT BROKE INTO 2 PIECES. THE OTHER 15 ROUND CHANNEL BLAKE HUB LESS DRAIN BROUGHT FROM GMH TO PMH FOR THEM TO TRY WAS TOO FLIMSY, KINKS ON ITSELF SO IT DID NOT DRAIN, AND DID NOT HAD A LONG ENOUGH OR FIRM ENOUGH AREA TO SECURE IT WITH SUTURE. THEY USED THEM YESTERDAY HAD A VERY DIFFICULT TIME TYING THE SECURING STITCH TIGHT ENOUGH TO HOLD IT WITHOUT CRIMPING THE DRAIN AND PREVENTING DRAIN FUNCTION. THE AREA WHERE IT WAS SUPPOSED TO BE SECURED WAS PROXIMAL TO THE BLACK DOT AND YET WAS SO SHORT THAT MINOR MOVEMENTS IN THE DRAIN WOULD CAUSE THE CHANNELS TO BE IN THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319836 ↗
• MalfunctionJun 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SEVERAL CONCERNS REGARDING THE CURRENT DRAIN SETUP. PATIENTS WERE EXPERIENCING SIGNIFICANT DISCOMFORT DURING REMOVAL, WHICH HAD BEEN DESCRIBED AS PAINFUL. ADDITIONALLY, THE FLANGES TEND TO STRETCH THE DRAIN WHEN MANIPULATED, INCREASING THE RISK OF THE DRAIN DETACHING UNINTENTIONALLY. THESE ISSUES NOT ONLY IMPACT PATIENT COMFORT BUT ALSO RAISE POTENTIAL SAFETY CONCERNS THAT NEED TO BE ADDRESSED PROMPTLY. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28MAY2025, THE FLANGE ON THE DRAIN CURLS UP ON ITSELF WHEN IT WAS STRETCHED. THEN THEY TUGGED ON IT TO DEMONSTRATE, IT BROKE INTO 2 PIECES. THE OTHER 15 ROUND CHANNEL BLAKE HUB LESS DRAIN BROUGHT FROM GMH TO PMH FOR THEM TO TRY WAS TOO FLIMSY, KINKS ON ITSELF SO IT DID NOT DRAIN, AND DID NOT HAD A LONG ENOUGH OR FIRM ENOUGH AREA TO SECURE IT WITH SUTURE. THEY USED THEM YESTERDAY HAD A VERY DIFFICULT TIME TYING THE SECURING STITCH TIGHT ENOUGH TO HOLD IT WITHOUT CRIMPING THE DRAIN AND PREVENTING DRAIN FUNCTION. THE AREA WHERE IT WAS SUPPOSED TO BE SECURED WAS PROXIMAL TO THE BLACK DOT AND YET WAS SO SHORT THAT MINOR MOVEMENTS IN THE DRAIN WOULD CAUSE THE CHANNELS TO BE IN THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319028 ↗
• MalfunctionJun 20, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT SEVERAL CONCERNS REGARDING THE CURRENT DRAIN SETUP. PATIENTS WERE EXPERIENCING SIGNIFICANT DISCOMFORT DURING REMOVAL, WHICH HAD BEEN DESCRIBED AS PAINFUL. ADDITIONALLY, THE FLANGES TEND TO STRETCH THE DRAIN WHEN MANIPULATED, INCREASING THE RISK OF THE DRAIN DETACHING UNINTENTIONALLY. THESE ISSUES NOT ONLY IMPACT PATIENT COMFORT BUT ALSO RAISE POTENTIAL SAFETY CONCERNS THAT NEED TO BE ADDRESSED PROMPTLY. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28MAY2025, THE FLANGE ON THE DRAIN CURLS UP ON ITSELF WHEN IT IS STRETCHED. THEN THEY TUGGED ON IT TO DEMONSTRATE, IT BROKE INTO 2 PIECES. THE OTHER 15 ROUND CHANNEL / BLAKE / HUBLESS DRAIN BROUGHT FROM GMH TO PMH FOR ME TO TRY IS TOO FLIMSY, KINKS ON ITSELF SO IT DOESN¿T DRAIN, AND DOESN¿T HAVE A LONG ENOUGH OR FIRM ENOUGH AREA TO SECURE IT WITH SUTURE. I USED THEM YESTERDAY HAD A VERY DIFFICULT TIME TYING THE SECURING STITCH TIGHT ENOUGH TO HOLD IT WITHOUT CRIMPING THE DRAIN AND PREVENTING DRAIN FUNCTION. THE AREA WHERE IT IS SUPPOSED TO BE SECURED IS PROXIMAL TO THE BLACK DOT, AND YET IS SO SHORT THAT MINOR MOVEMENTS IN THE DRAIN WILL CAUSE THE CHANNELS TO BE IN THE DRAIN T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296965 ↗
• MalfunctionJan 2, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE TIP OF THE WOUND DRAIN WAS PLACED IN THE INCISION FOR POST OP DRAINING. THE PATIENT WAS BROUGHT BACK TO SURGERY, AND IT WAS FOUND THAT THE TIP OF THE DRAIN THAT WAS PLACED IN THE INCISION WAS CLOSED AS A MANUFACTURER DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054378 ↗
• MalfunctionDec 30, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE TIP WAS PLACED IN THE INCISION FOR POST OP DRAINING. THE PATIENT WAS BROUGHT BACK TO SURGERY, AND IT WAS FOUND THE TIP OF THE WOUND DRAIN THAT WAS PLACED IN THE INCISION WAS CLOSED AS A MANUFACTURER DEFECT. THEY HAVE REPORTED THIS TO MEDLINE. THEY ADVISED TO ALSO REPORT TO THEM AS MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035163 ↗
• InjuryJul 2, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO HOLE IN THE DRAIN THAT WAS IN THE PATIENTS BREAST. WHEN THE DRAIN WAS PULLED OUT OF THE PATIENTS BREAST TO TRY AND FLUSH FLUID THROUGH THE DRAIN, THAT WAS WHEN IT WAS FOUND THAT THERE WAS NO HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 19655071 ↗
• InjuryJun 7, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT CHANNEL DRAIN INCOMPLETELY REMOVED FROM PATIENT, WITH REMNANT PIECE LODGED IN PATIENT'S ABDOMEN. PATIENT UNDERWENT LIVER SURGERY AND HAD TWO ROUND JP DRAINS INTRA OPERATIVELY. DUE TO DECREASED SEROSANGUINOUS DRAINAGE, IT WAS APPROPRIATE CLINICAL TIMING FOR REMOVAL. ON THE DATE OF REMOVAL, AREA WAS PREPPED, SUTURE ONLY WAS CUT, DRAIN WAS BRIEFLY ROTATED TO ENSURE SUTURE WAS REMOVED IN ITS ENTIRETY. DRESSING SUPPLIES WERE GATHERED AND WHEN ATTENTION WAS TURNED TO REMOVE THE DRAIN, IT HAD ALREADY FALLEN OUT. BASED ON THE TIP OF THE DRAIN, AS WELL AS THE LENGTH OF THE REMOVED DRAIN TUBING, IT WAS CLEAR IT HAD NOT BEEN REMOVED IN ITS ENTIRETY. FOLLOW UP IMAGING REVEALED RETAINED FRAGMENT OF THE JP DRAIN IN THE ABDOMEN. REVIEW OF SURGICAL SUPPLIES THAT MAY HAVE CONTRIBUTED TO THE INTEGRITY OF JP DRAIN USED. IT WAS NOT THOUGHT TO BE PRACTICE RELATED AS THEY PERFORMED THE REMOVAL. THEY HAD CUT ONLY THE SUTURE WITH THE SUTURE SCISSORS, NEVER HAVING MADE ANY CONTACT WITH THE DRAIN TUBING ITSELF. THE TUBING WAS NOT PULLED ON AT ALL, AND SIMPLY FELL OUT WHEN THE DRAIN WAS PICKED UP WITH THE INTENTION OF REMOVING IT. THE SEGMENT WHERE THE FRACTURE OCCURRED WAS INSIDE OF THE

  Patient problems: Foreign Body In Patient

  MAUDE report 19490073 ↗
• InjuryMay 14, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WOUND DRAIN WAS INCOMPLETELY REMOVED FROM THE PATIENT WITH REMNANT PIECE LODGED IN ABDOMEN OF THE PATIENT. PATIENT UNDERWENT LIVER SURGERY AND HAD TWO ROUND JP DRAINS INTRA-OPERATIVELY. DUE TO DECREASED SEROSANGUINOUS DRAINAGE, IT WAS APPROPRIATE CLINICAL TIMING FOR REMOVAL. ON THE DATE OF REMOVAL, AREA WAS PREPPED, SUTURE ONLY WAS CUT, DRAIN WAS BRIEFLY ROTATED TO ENSURE SUTURE WAS REMOVED IN ITS ENTIRETY. DRESSING SUPPLIES WERE GATHERED AND WHEN ATTENTION WAS TURNED TO REMOVE THE DRAIN, IT HAD ALREADY FALLEN OUT. BASED ON THE TIP OF THE DRAIN, AS WELL AS THE LENGTH OF THE REMOVED DRAIN TUBING, IT WAS CLEAR IT HAD NOT BEEN REMOVED IN ITS ENTIRETY. FOLLOW UP IMAGING REVEALED RETAINED FRAGMENT OF THE JP DRAIN IN THE ABDOMEN. THEY REVIEWED SURGICAL SUPPLIES THAT MAY HAVE CONTRIBUTED TO THE INTEGRITY OF JP DRAIN USED. PER FOLLOW UP RECEIVED VIA EMAIL (B)(6)2024, THEY PERFORMED THE REMOVAL OF WOUND DRAIN THEMSELVES. THEY HAD CUT ONLY THE SUTURE WITH THE SUTURE SCISSORS, NEVER HAVING MADE ANY CONTACT WITH THE DRAIN TUBING ITSELF. THE TUBING WAS NOT PULLED ON AT ALL, AND SIMPLY FELL OUT WHEN THE DRAIN WAS PICKED UP WITH THE INTENTION OF REMOVING IT. THE SEGMENT WHERE

  Patient problems: Foreign Body In Patient

  MAUDE report 19309385 ↗
• MalfunctionJul 6, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SILICONE CHANNEL DRAIN CONTAINED AN EYE LASH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14934435 ↗
• InjuryAug 14, 2020Break; Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DRAIN BROKE AND WAS RETAINED IN THE PATIENT. THE PATIENT HAD TO RETURN TO THE OR TO HAVE THE DRAIN REMOVED. THE DRAIN IS WITH RISK MANAGEMENT. PER ADDITIONAL INFORMATION FROM MEDWATCH RECEIVED, THE DRAIN WAS PULLED AND BROKE.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10410319 ↗
• InjuryDec 23, 2019Break; Entrapment of Device

  IT IS REPORTED THE DRAIN BROKE OFF AT THE HUB AND THE REMAINING PIECE WAS RETAINED INSIDE THE PATIENT. THE DRAIN WAS PLACED ON (B)(6) 2019 AND REMOVAL WAS ATTEMPTED ON (B)(6) 2019. THE RETAINED PIECE WAS REMOVED BY THE PROVIDER. IT IS NOT REPORTED HOW THE RETAINED PIECE WAS REMOVED BY THE PROVIDER.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 9512412 ↗
• MalfunctionDec 11, 2019Break

  IT WAS REPORTED THAT THE DRAIN BROKE AT THE HUB DURING REMOVAL.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9452014 ↗