Skip to content

Channel Drain 072227Recalls & reported problems

C. R. Bard, Inc. · Channel Drain, 10Fr. Round Hubless Full Fluted with 3.2mm Trocar · Class 1

Quick summary

This is a Bard Channel Drain, a silicone wound drain with a trocar used to drain fluid from a surgical wound. The 47 reports mostly describe the drain tip blunting, fraying or snapping off during insertion or removal, the trocar bending, and the tubing breaking or pulling loose from the trocar. Seven reports involve injuries, including pieces left inside patients that had to be removed surgically, and there are no deaths. No recalls name this device, and reports are about the same as the prior 12 months (9 versus 10).

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
46
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00801741049873), received between Mar 28, 2017 and May 14, 2026 — classified as 7 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (11 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 3 reportsOct 2025: 1 reportsNov 2025: 2 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 2 reportsMar 2026: 2 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Dull, Blunt11
  • Material Fragmentation9
  • Break4
  • Incorrect Measurement4
  • Disconnection3
  • Device Contamination with Chemical or Other Material2
  • Device Dislodged or Dislocated2
  • Material Too Soft/Flexible2

Patient problems

  • No Clinical Signs, Symptoms or Conditions23
  • No Consequences Or Impact To Patient14
  • No Known Impact Or Consequence To Patient7
  • Foreign Body In Patient5
  • Hematoma3
  • No Patient Involvement3
  • Insufficient Information2
  • No Information1

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 14, 2026Material Fragmentation

    IT WAS REPORTED THAT A REGISTERED NURSE WAS ATTEMPTING TO STRIP THE JP (JACKSONPRATT) DRAIN, AND THE TUBING BROKE APPROXIMATELY 6 INCHES FROM THE INSERTION SITE ON THE WOUND DRAIN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25174129 ↗
  • MalfunctionMar 30, 2026Incorrect Measurement; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE CUSTOMER RECENTLY CONVERTED OUR BLAKE DRAINS TO THE BD 072227 AND 072229 DRAINS. CUSTOMER WAS RECEIVING SOME COMPLAINTS ON THE BD DRAINS, PRIMARILY ON THE SIZE OF THE TROCAR COMPARED TO THE BLAKE DRAINS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24719024 ↗
  • InjuryMar 25, 2026Material Fragmentation

    IT WAS REPORTED THAT A FEW DAYS AGO, AT THE FACILITY, STAFF WAS ATTEMPTED TO REMOVE A WOUND DRAIN FROM A PATIENT. THE DRAIN SNAPPED OFF INTO THE PATIENT. THEY HAD TO TAKE THE PATIENT TO THE OPERATING ROOM FOR REMOVAL OF THE RETAINED DRAIN PIECE. THEY UNSURE OF WHAT THEY DID WITH THE DRAIN PIECE WHETHER THAT WAS SENT TO PATHOLOGY FOR EVALUATION OR JUST DISCARDED. THEY JUST WANTED TO REPORT THAT INCIDENT IN CASE OTHER HAVE REPORTED A SIMILAR ISSUE.

    Patient problems: Foreign Body In Patient

    MAUDE report 24690499 ↗
  • MalfunctionFeb 27, 2026Material Twisted/Bent

    IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD REQUESTED A SAMPLE OF (B)(6). THE CUSTOMER STATED THAT THEY HAD A DOCTOR WHO USED PRODUCT 072227 AND HAD NOT LIKED THE TROCAR ATTACHED. THE DOCTOR WAS CURRENTLY USING 072227 WHICH WAS A DRAIN WITH A TROCAR. THEY WERE STATING THE TROCAR BENDS AND HAS ASKED TO FIND THEM SOMETHING ELSE TO USE. THE ONE SENT WAS OFF CONTRACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24475628 ↗
  • MalfunctionFeb 27, 2026Material Twisted/Bent

    IT WAS REPORTED THAT THEY STATED THE WOUND DRAIN BENDS AND HAD ASKED THEY FOUND THEM SOMETHING ELSE TO USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24475111 ↗
  • MalfunctionJan 23, 2026Fracture; Material Split, Cut or Torn

    IT WAS REPORTED THAT THEY HAVE HAD NUMEROUS SAFETY CONCERNS ARISE WITH THE WOUND DRAIN. WHEN PLACING THE WOUND DRAIN IN PATIENT, THE SILICONE DRAIN TUBING RIPPED FROM THE TROCHAR BEFORE IT COULD BE FULLY PULLED THROUGH THE SKIN. THERE WAS ALSO ONE OTHER EVENT REPORTED BY A DIFFERENT PHYSICIAN FOR THE SAME ISSUE. THEY NEED A RESOLUTION TO THIS ISSUE AS SOON AS POSSIBLE. THIS OCCURRED DURING DR. (B)(6) CASE, AND THEY CANNOT HAVE IT HAPPEN AGAIN. THEY ARE REQUESTING TO COME OUT THERE TO HELP RESOLVE THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24171729 ↗
  • InjuryNov 26, 2025Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT AFTER REMOVAL OF A JP (JACKSON-PRATT) DRAIN THAT WAS PLACED IN SURGERY THE DAY PRIOR, THE TIP OF THE DRAIN APPEARED BROKEN. IMAGING CONFIRMED THAT THE DRAINAGE TIP WAS RETAINED IN THE BODY, WITH NO VISIBLE EXTENSION OF THE CATHETER OUTSIDE THE SKIN. THE RETAINED ITEM WAS SURGICALLY REMOVED. IT WAS ABOUT 8.5CM IN LENGTH.

    Patient problems: Foreign Body In Patient

    MAUDE report 23658428 ↗
  • MalfunctionNov 7, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

    IT WAS REPORTED THAT ONE OF THE SURGEONS WAS NOT HAPPY WITH THE 10MM FULLY FLUTED ROUND WOUND DRAIN 072227 FROM BD. THEY SAID THAT THEY HAD A PATIENT WITH A HEMATOMA CAUSED BY THE DRAIN. WHEN THEY LOOK AT THE BD DRAIN COMPARED TO THE CARDINAL ONE, THEY WERE USED THE TROCAR WAS LARGER IN DIAMETER AND THE DRAIN GETS LARGER WHERE THE FLUTES STOP AND THE TUBING BEGINS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER CUSTOMER EMAIL RESPONSE RECEIVED ON 04NOV2025. IT WAS REPORTED THAT A DRAIN WAS AVAILABLE IN THEIR OFFICE. THEY ARE ALL THE SAME, NO PARTICULAR LOT. THAT WAS A DESIGN ISSUE. A SURGEON COMPLAINED ABOUT THE AREA WHERE THEY WOULD TIE A SUTURE, WAS TOO FLIMSY AND WOULD FOLD OVER OR FLATTEN OUT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23497747 ↗
  • InjuryOct 30, 2025Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT THE PATIENT RETURNED TO OPERATING ROOM FOR UNPLANNED SURGERY TO REMOVE A RETAINED DRAIN CATHETER TIP. THIS OCCURRED AFTER UNSUCCESSFUL REMOVAL OF DRAIN AT BEDSIDE. SUCCESSFUL RETRIEVAL OF DRAIN TIP IN THE OPERATING ROOM, SENT TO PATHOLOGY.

    Patient problems: Foreign Body In Patient

    MAUDE report 23427658 ↗
  • MalfunctionSep 30, 2025Incorrect Measurement; Incorrect Measurement

    IT WAS REPORTED THAT SMMC HAD STARTED RECEIVING THE BD DRAINS AND ONE OF THE SURGEONS WAS NOT HAPPY WITH THE 10MM FULLY FLUTED ROUND WOUND DRAIN FROM BD. HE HAS SAID THAT HE HAS HAD A PATIENT WITH A HEMATOMA CAUSED BY THE DRAIN. WHEN LOOK AT THE BD DRAIN COMPARED TO THE CARDINAL ONE, THEY WERE USING THE TROCAR WAS LARGER IN DIAMETER AND THE DRAIN GET LARGER WHERE THE FLUTES STOP AND THE TUBING BEGINS.

    Patient problems: Hematoma

    MAUDE report 23179865 ↗
  • InjurySep 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED THAT ONE OF THE SURGEONS WAS NOT HAPPY WITH THE 10MM FULLY FLUTED ROUND WOUND DRAIN 072227 FROM BD. THEY SAID THAT THEY HAD A PATIENT WITH A HEMATOMA CAUSED BY THE DRAIN. WHEN THEY LOOK AT THE BD DRAIN COMPARED TO THE CARDINAL ONE, THEY WERE USED THE TROCAR WAS LARGER IN DIAMETER AND THE DRAIN GETS LARGER WHERE THE FLUTES STOP AND THE TUBING BEGINS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

    Patient problems: Hematoma

    MAUDE report 23084337 ↗
  • MalfunctionSep 11, 2025Dull, Blunt; Dull, Blunt

    IT WAS REPORTED THAT THE DOCTOR RAISED SERIOUS SAFETY CONCERNS REGARDING THE RECENTLY CONVERTED BD JP DRAINS 072227 ¿ 10FR CHANNEL. ACCORDING TO THEIR FEEDBACK, THE NEW WOUND DRAINAGE ARE MORE DIFFICULT TO BEND AND LACK THE SHARPNESS OF THE PREVIOUSLY USED CARDINAL DRAINS JP-2227 ¿ 10FR CHANNEL. THAT REDUCED SHARPNESS WAS CAUSED EXCESSIVE STRETCHING OF THE SKIN AND SURROUNDING TISSUE DURING PLACEMENT, WHICH POSES A RISK TO PATIENT SAFETY. IN A RECENT CERVICAL CASE, THE ISSUE NEARLY RESULTED IN PATIENT HARM, AS AN ADDITIONAL INCISION HAD TO BE MADE JUST TO INSERT THE DRAIN SIGNIFICANTLY INCREASING THE RISK OF POSTOPERATIVE COMPLICATIONS SUCH AS HEMATOMA. DUE TO THESE CONCERNS, DOCTOR REQUESTED AN IMMEDIATE RETURN TO STOCKING THE ORIGINAL CARDINAL DRAINS FOR THEIR CASES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23028122 ↗
  • InjuryJun 12, 2025Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT A CHANNEL DRAIN (BD ITEM 072227) BROKE DURING REMOVAL, RESULTING IN A 4-INCH FRAGMENT BEING RETAINED INSIDE THE PATIENT AND REQUIRING SURGICAL INTERVENTION FOR REMOVAL. THIS INCIDENT HAS RAISED CONCERNS ABOUT THE INTEGRITY OF THE PRODUCT. THE TEAM IS SEEKING TO DETERMINE WHETHER THERE ARE ANY KNOWN ISSUES OR RECALLS ASSOCIATED WITH THIS SPECIFIC ITEM.

    Patient problems: Foreign Body In Patient

    MAUDE report 22194614 ↗
  • MalfunctionMay 22, 2025Incorrect Measurement; Incorrect Measurement

    IT WAS REPORTED THAT WOUND DRAINAGE 072187 WAS BIGGER THAN A 10FR IN DIAMETER AND 072227 THE DRAIN TAPERS AND BECOMES A LARGER DIAMETER AT THE TOP BOTH OF THOSE CAUSED ISSUES AS NONE ARE THE CORRECT SIZE. ALSO, THE MATERIAL THE DRAIN WAS MADE OF SILICONE CAUSES A LOT OF RESISTANCE WHEN TRIED TO REMOVE THE DRAIN FROM THE PATIENT. THAT COULD CAUSE TISSUE DAMAGE FOR THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22070314 ↗
  • MalfunctionApr 4, 2025Dull, Blunt; Dull, Blunt

    IT WAS REPORTED THAT SURGEON CAME TO THEM AND SAID THE NEEDLE OF WOUND DRAIN WAS NOT AS SHARP AND DOES NOT PUNCTURE AS WELL. PER CUSTOMER VIA PHONE ON 02APR2025, IT WAS REPORTED THAT THE DOCTOR NOTICED THE PACKAGING CHANGED FROM BARD TO BD AND HE IS CONCERNED THAT THE NEEDLES ARE NOT AS SHARP AS THEY USED TO BE. NO INJURY TO PATIENTS AND LOT NUMBER WAS NOT PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21772667 ↗
  • MalfunctionMar 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THEY WERE HAVING SOME ISSUES WITH A FEW OF THEIR WOUND DRAINS THAT THEY HAD CONVERTED FROM CARDINAL TO BARD. PHYSICIANS WERE CONCERNED ABOUT THE BARD DRAIN NOT BEING TAPERED (PCN #072227), (PCN #072229), (PCN #072230) AND THEY WERE HAVING ISSUES WITH IT STAYING IN CORRECTLY. THE BARD ITEM NUMBERS THAT THEY WERE EXPERIENCING ISSUES WITH WERE: (PCN #072227), (PCN #072229 ), (PCN #072230).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21583155 ↗
  • MalfunctionMar 3, 2025Component Misassembled; Component Misassembled

    IT WAS REPORTED THAT THEY WERE HAVING SOME ISSUES WITH A FEW OF THEIR WOUND DRAINS THAT THEY HAD CONVERTED FROM CARDINAL TO BARD. PHYSICIANS WERE CONCERNED ABOUT THE BARD DRAIN NOT BEING TAPERED AND THEY WERE HAVING ISSUES WITH IT STAYING IN CORRECTLY. THE BARD ITEM NUMBERS THAT THEY WERE EXPERIENCING ISSUES WITH WERE: (PCN #(B)(6)).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21504510 ↗
  • MalfunctionDec 26, 2024Disconnection; Disconnection

    IT WAS REPORTED THAT DUE TO THE NEW BD CONTRACTED THEY HAVE MOVED TO THE 10FR BD WOUND DRAIN. THIS WAS USED ON A PATIENT THE OTHER DAY AND THERE WERE SOME SAFETY CONCERNS FOR THEIR PRODUCT. THE BD CHANNEL DRAIN 10FR ROUND HUBLESS WAS FULL FLUTED WITH 3.2MM TROCAR. PHYSICIAN STATED THIS PRODUCT WAS UNSAFE TO USE. THE PRODUCT WAS VERY DIFFICULT TO PIERCE THROUGH THE SKIN. BECAUSE OF THIS DIFFICULTY, THIS PRODUCT WAS DANGEROUS TO PATIENTS, STAFF, EQUIPMENT, AND TO DRAPES DUE TO RISK OF NEEDLE STICK OR PUNCTURE OR SHARPS INJURY. THIS PRODUCT CAME APART INSIDE THE PATIENT. STAFF HAD TO DIG THE END OUT OF THE PATIENT'S SKIN TO USE IT. THE STAFF FELT THIS PRODUCT WAS LOW QUALITY OR HIGH RISK FOR INJURY COMPARED TO PREVIOUSLY USED PRODUCT. STAFF WAS REQUESTING REPLACEMENT SAFER PRODUCT. PATIENT WAS NOT HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21018298 ↗
  • MalfunctionApr 24, 2024Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT THE SILICONE CHANNEL DRAIN BROKE DURING THE PROCEDURE. THE PHYSICIAN USED A NEW ONE AND IT WORKED WITHOUT ANY PROBLEMS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19170011 ↗
  • MalfunctionMar 20, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THERE WAS HAIR IN STERILE PACKAGE OF WOUND DRAIN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18939415 ↗
  • MalfunctionMar 14, 2024Incorrect Measurement; Incorrect Measurement

    IT WAS REPORTED THAT IT WAS FOUND TO HAVE NARROWING IN PLASTIC WITH A SMALL OPENING IN THE SILICONE WOUND DRAIN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18903368 ↗
  • MalfunctionOct 12, 2022Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT DRAIN PART CAME OFF FROM THE TROCAR DURING USE. IT SEEMED THAT THERE WAS NO TENSION AND USER DID NOT APPLY ANY EXTRA FORCE TO THE DISCONNECTED PART. PER FOLLOW-UP INFORMATION RECEIVED ON 10OCT2022, THE DRAIN PART SEEMED TO BE BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15587211 ↗
  • MalfunctionJul 21, 2021Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT THE BARD DRAIN WAS BROKEN FROM THE TROCAR INSIDE THE PATIENT'S BREAST POCKET.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12206807 ↗
  • MalfunctionMay 17, 2021Material Separation; Material Separation

    IT WAS REPORTED THAT THE TUBING WOULD SEPARATE FROM THE TROCAR WHEN IT WAS BEING PULLED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11831805 ↗
  • InjuryFeb 8, 2021Suction Failure; Suction Failure

    IT WAS REPORTED THAT THE WOUND DRAIN WAS TOO SOFT AND COLLAPSED WITH SUCTION. IT WAS ALSO REPORTED THAT THERE WAS DIFFICULTY WITH THE DRAIN HOLDING OR MAINTAINING SUCTION WHEN HOOKED TO THE JACKSON-PRATT DRAIN. THE PHYSICIAN STATED THAT THE BULB WOULD HAVE LOTS OF NEGATIVE PRESSURE WITHIN AN HOUR AND HENCE, INSTRUCTED THE USER ON HOW TO "BURP" THE AIR OUT AND REAPPLY SUCTION. ALSO STATED THEY DID NOT HAVE PROBLEM WITH PRIOR DRAIN. AGAIN, IT WAS REPORTED THAT THE DRAINS DID NOT HOLD SUCTION AND LEAKED. ONE PATIENT HAD A HEMATOMA THAT RESULTED IN A REPEATED OPERATOR TRIP FOR EVACUATION. HX: THE PATIENT GOT A HEMATOMA LAST WEEK AND HAD TO COME BACK TO SURGERY.

    Patient problems: Hematoma

    MAUDE report 11293548 ↗

Other CATHETER, IRRIGATION devices

All CATHETER, IRRIGATION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.