Silicone Round Drain 0070310Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00801741049460), received between Mar 23, 2018 and May 17, 2026 — classified as 10 injuries, 24 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE SPD DEPARTMENT FOUND, UPON PULLING CASES, THAT A FEW OF THE TUBES HAD BLACK DOTS ON THEM (NOT ALL PACKAGES). ADDITIONAL PRODUCTS UNDER ANOTHER REFERENCE NUMBER WERE ALSO NOTED TO HAVE BLACK DOTS ALONG THE TUBING. IT WAS FURTHER REPORTED THAT REF (B)(4) HAD THESE BLACK DOTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196453 ↗
• MalfunctionMar 23, 2026Material Fragmentation

  IT WAS REPORTED THAT WHILE STRIPPING THE WOUND DRAIN, REGISTERED NURSE PLACED ONE HAND AT TOP OF DRAIN AND WITH THE VERY FIRST PULL TO STRIP THE DRAIN SNAPPED IN HALF. BLOOD PATHOGEN EXPOSURED TO STAFF. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL 28APR2026, PLEASE ADD THE ADDITIONAL PATIENT QUALIFIERS TO THE COMPLAINT: MALE, 35M 127KG, AFRICAN AMERICAN, 70.98¿. MEDICAL INTERVENTION WAS NOT REQUIRED AS, "PA OK WITH DRAIN REMOVAL AT THIS TIME BUT NORMALLY WOULD HAVE REMAINED IN PLACE UNTIL THE AM." NO ADDITIONAL INFORMATION IS AVAILABLE. NO SAMPLE IS AVAILABLE. ONCE THIS INFORMATION HAS BEEN ASSESSED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24664972 ↗
• MalfunctionFeb 23, 2026Complete Blockage

  IT WAS REPORTED THAT DURING USE THE WOUND DRAIN WAS FOUND TO BE BLOCKED BY HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421912 ↗
• MalfunctionJun 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE WOUND DRAIN WAS BROKEN WHEN THE NURSE REMOVED THE DRAIN FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123546 ↗
• InjuryMar 7, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE INCIDENT REPORT WAS FILED ON AS THEY HAD TO RETURN TO SURGERY FOR A HEMATOMA EVACUATION BECAUSE THE DRAIN DID NOT WORK AS IT SHOULD HAVE. THIS IS NOT THE FIRST PATIENT THAT THEY HAD THIS PROBLEM WITH. THIS COMPLAINT IS FOR PRODUCT (PCN #(B)(4)) AND (PCN #(B)(4)).

  Patient problems: Hematoma

  MAUDE report 21547545 ↗
• MalfunctionFeb 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THEY HAD AN END USER WHO HAD BEEN HAVING ISSUES WITH THE MFG# 0070310.THE NURSE WAS MILKING THE WOUND DRAIN AND THE TUBING SNAPPED IN THE MIDDLE WHERE THE NURSE WAS MILKING THAT. THAT HAD HAPPENED ON TWO OCCASIONS. PER CUSTOMER VIA PHONE ON 05FEB2025, IT WAS REPORTED THAT THE DEVICE HAD BEEN THROWN AWAY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21346233 ↗
• MalfunctionFeb 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THIS ISSUE HAD HAPPENED 2X IN WOUND DRAIN TROCARS. THE NURSE WAS MILKING THE DRAIN AND THE TUBING SNAPPED IN THE MIDDLE WHERE THEY WERE MILKING WOUND DRAINS. PER CUSTOMER VIA PHONE ON 05FEB2025, IT WAS REPORTED THAT THE DEVICE HAD BEEN THROWN AWAY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343301 ↗
• MalfunctionDec 13, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT WOUND DRAIN WAS SUPPOSED TO BE 1/8 INCH BUT CAME AS 3/16 INCH. THE PACKAGING STATED IT SHOULD BE 1/8 INCH. CUSTOMER HAD 2 CAME IN THIS WAY WITH THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925351 ↗
• InjuryAug 25, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER ASKED IF THERE WAS ANY DEVICE RECOMMENDATIONS ON WHAT TO DO WHEN THE DRAIN WAS DIFFICULT TO REMOVE. THE PATIENT HAD MINIMAL DRAINAGE AND IT WAS APPROPRIATE TO REMOVE THE DEVICE. THE TEAM WAS AT THE BEDSIDE, PATIENT MEDICATED FOR PAIN AND DEVICE WAS THEN PULLED OUT FROM THE PATIENT. HOWEVER, THE PROVIDER WAS MEETING RESISTANCE AND THE TUBE WAS NOT COMING OUT. PER FOLLOW UP VIA EMAIL ON 09AUG2023, CUSTOMER STATED THAT THE ITEM HAS BEEN DISCARDED. THE PATIENT WAS SAFE AND WELL. CUSTOMER ASKED WAS THERE A STRENGTH TEST AS TO HOW MUCH WITH THE TUBE CAN HANDLE. WAS THERE A LIMIT TO HOW MUCH THE TUBE CAN BE PULLED BEFORE IT BREAKS. AND ALSO ASKED WAS IT BEST PRACTICE TO PLACE THE DRAIN ON TRACTION TO HELP EASE THE DEVICE OUT FORM A WOUND.

  Patient problems: Pain

  MAUDE report 17622734 ↗
• MalfunctionOct 18, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE BARD WOUND DRAIN WAS FOUND TO BE BLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623868 ↗
• MalfunctionAug 23, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE WOUND DRAINS MATERIAL#: 0080720, MATERIAL#: 0080710 AND MATERIAL#: 0070310 DID NOT FIT WITH THE SILICONE EVACUATOR BULBS (MATERIAL#: 0070740). CUSTOMER STATED THAT THE FIRST TWO DRAINS (MATERIAL#: 0080720, MATERIAL#: 0080710) DID NOT COME WITH AN ADAPTOR. THE LAST ONE MATERIAL#: 0070310 HAD AN ADAPTOR BUT DID NOT FIT WITH THE EVACUATOR BULB. PER FOLLOW-UP VIA EMAIL ON 02AUG2022, BD REPRESENTATIVE SUGGESTED CUSTOMER THAT MATERIAL#: 0080710 AND MATERIAL#: 0080720 WERE PVC DRAINS THAT WERE NOT CONNECTING. AND STATED THAT THEY WERE NOT LIKE MATERIALS, AS A PVC DRAIN CANNOT CONNECT TO THE SILICONE BULB. REPRESENTATIVE ADVISED THAT THE SILICONE DRAIN MATERIAL#: 0070310 SHOULD CONNECT WITH SILICONE EVACUATOR MATERIAL#: 0070740 SINCE THEY BOTH WERE SILICONE MATERIALS, AND THE CONNECTORS WERE WITHIN THE SILICONE DRAIN PACKAGING. PER ADDITIONAL INFORMATION RECEIVED ON 15AUG2022, CUSTOMER REPORTED THAT THEY WERE STILL HAVING ISSUES WITH DRAINS. THE BULBS THEY ORDERED WERE NOT THE GRENADE TYPE. PER ADDITIONAL INFORMATION RECEIVED ON 16AUG2022, CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH SOME HEMOVAC DRAINS (MATERIAL#: 0043650). THEY USED JACKSON-PRATT (J/P) DRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274645 ↗
• MalfunctionMay 24, 2022Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCAR TIP OF THE BARD WOUND DRAIN WAS NOT SHARP ENOUGH TO PENETRATE THE TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492056 ↗
• InjuryJan 5, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE JACKSON-PRATT WOUND DRAIN HAD BROKEN. ADVANCED PRACTICE PROVIDERS WERE CALLED TO BEDSIDE TO EVALUATE. PATIENT NOTED TO HAVE PROXIMAL CATHETER STILL IN CRANIUM OR SUTURE IN PLACE. DISTAL DRAIN WAS NOT ATTACHED. PROXIMAL CATHETER WAS FOUND WITH DRY BLOOD AT THE EXIT SITE, CATHETER WAS REMOVED, SUTURED SITE. PATIENT WAS ASSESSED AND FOUND TO HAVE A L HEMIPARESIS AND CODE BAT WAS CALLED. CT REVEALED NEW INTRACEREBRAL BRAIN HEMORRHAGE UNDER CRANIAL FLAP. LEVEL ONE TO OPERATION ROOM AFTER THE PHYSICIAN WAS NOTIFIED.

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

  MAUDE report 13169147 ↗
• InjuryJul 16, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DRAIN WAS PLACED IN A BELOW KNEE AMPUTEE AND UPON REMOVAL OF THE DRAIN IT WAS BROKEN, AND THE PATIENT WENT TO SURGERY TO REMOVE THE RETAINED PORTION AND IT WAS RETAINED. ALSO, CUSTOMER WOULD LIKE IT ANALYZED TO DETERMINE WHAT OPPORTUNITIES BARD MAY FIND FOR FUTURE USE. PER CUSTOMER VIA PHONE ON (B)(6) 2021, THE DRAIN BROKE UPON REMOVAL, SURGERY WAS PERFORMED TO REMOVED RETAINED PRODUCT. NO ADDITIONAL MEDICAL TREATMENT OR INTERVENTION WAS REQUIRED DUE TO THE BROKEN DRAIN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 12181424 ↗
• MalfunctionJun 30, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE USER PLACED A 1/8¿ DRAIN ON A PATIENT AND NOTICED THAT THE PROXIMAL END WAS PLUGGED. SO, THE USER CUT THE END OFF, CHECKED FOR PATENCY AND LEFT THE DRAIN IN. THIS WAS THE SAME SITUATION THE USER HAD WITH THE DRAIN WHILE BACK IN THORACIC SURGERY. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096798 ↗
• MalfunctionApr 15, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCAR OF THE WOUND DRAIN WAS NOT SHARP ENOUGH TO GO THROUGH THE SKIN. IT WAS STATED THAT A SCALPEL WAS USED TO CUT THE SKIN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11674999 ↗
• MalfunctionMar 30, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WERE MARKS THAT LOOKED LIKE CUT WITH SCISSORS ON THE PACKAGE. IT WAS STATED THAT THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590555 ↗
• MalfunctionMar 30, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBE OF THE BARD WOUND DRAIN WAS FOUND TO BE CUT. IT WAS STATED THAT IT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590554 ↗
• InjuryFeb 4, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE THREE TROCAR DRAINS WERE DULL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Consequences Or Impact To Patient

  MAUDE report 11279657 ↗
• InjuryDec 16, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCARS ON THE BARD DRAINS WERE DULL AND DANGEROUS. IN ADDITION, THE SAME ISSUE WAS FOUND WITH THE SAME DRAINS USED AT GEORGETOWN FACILITY. PER FOLLOW UP VIA EMAIL ON 24NOV2020, AS TROCAR HAS BEEN INSERTED WITH EXTREME DIFFICULTY AND PATIENT NEEDED RESTITCHING OF FASCIA THAT CAME APART WHILE ATTEMPTING TO INSERT TROCAR. ALL ISSUE OCCURRED DURING SURGICAL PROCEDURE. NO EXTRA INTERVENTION REQUIRED APART FROM EXTRA STITCHES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11023303 ↗
• InjuryDec 16, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCARS ON THE BARD DRAINS WERE DULL AND DANGEROUS. IN ADDITION THE SAME ISSUE WAS FOUND WITH THE SAME DRAINS USED AT GEORGETOWN FACILITY. PER FOLLOW UP VIA EMAIL ON 24NOV2020 THE TROCAR WAS INSERTED WITH EXTREME DIFFICULTY AND THE PATIENT NEEDED RESTITCHING OF FASCIA THAT CAME APART WHILE ATTEMPTING TO INSERT THE TROCAR. ALL THE ISSUES OCCURRED DURING THE SURGICAL PROCEDURE. NO EXTRA INTERVENTION REQUIRED APART FROM EXTRA STITCHES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11023295 ↗
• InjuryDec 15, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE BARD TROCARS WERE NOT SHARP. PER FOLLOW UP VIA EMAIL ON 24NOV2020, AS TROCAR HAS BEEN INSERTED WITH EXTREME DIFFICULTY AND PATIENT NEEDED RESTITCHING OF FASCIA THAT CAME APART WHILE ATTEMPTING TO INSERT TROCAR. ALL ISSUE OCCURRED DURING SURGICAL PROCEDURE. NO EXTRA INTERVENTION REQUIRED APART FROM EXTRA STITCHES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11012361 ↗
• MalfunctionOct 23, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TWO TROCAR DRAINS WERE DULL, IN WHICH 5 PATIENTS AND THREE SURGEONS WERE INVOLVED WITH THIS TROCAR ISSUE. AS PER FOLLOW UP ON 01OCT2020, SIX USED SAMPLES WERE RETURNED FROM LOT # NGES0200; HENCE THE RECORDS WERE CREATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731235 ↗
• MalfunctionOct 23, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE ROUND SILICONE DRAIN WAS LESS SHARP AND HAD GREAT DIFFICULTY TO INSERT TO THE BACK OF THE PATIENT.

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

  MAUDE report 10727840 ↗
• MalfunctionOct 2, 2020Unclear Information; Component Missing; Therapeutic or Diagnostic Output Failure; Unclear Information

  IT WAS REPORTED THAT THE DRAIN DEVICE WAS FOUND NOT TO BE GRADUATED AFTER USE. THERE WAS NO BLACK SCALE ON THE DRAIN TUBE. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 23SEP2020, THERE WAS NO BLACK SCALE ON THE SURFACE OF THE DRAIN.

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

  MAUDE report 10623631 ↗