Closed Wound Suction V0043610Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741051586), received between Jul 2, 2018 and Jan 30, 2026 — classified as 4 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Dull, Blunt

  IT WAS REPORTED BY A CUSTOMER FROM ADVENT HEALTH CASTLE ROCK HAD REPORTED CONCERNS ABOUT THE DULLNESS OF DRAIN 043610 AND HAD ASKED ABOUT SHARPER ALTERNATIVE OPTIONS. THE CUSTOMER, WHO WAS THE SPINE/NEURO COORDINATOR AT CASTLE ROCK, HAD HOPED TO MEET TO REVIEW DIFFERENT DRAIN OPTIONS FOR ONE OF THEIR SPINE PHYSICIANS. THEY EXPLAINED THAT THE DOCTOR HAD BEEN USING THE BD REFERENCE NUMBER 0043610, BUT THE HAD BEEN STRUGGLING TO PERFORATE THE SKIN WITH IT. THEY PREFERRED USING MEDLINE 10FR 1/8" DRAINS, WITH PART NUMBER DYNJWE402.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228925 ↗
• MalfunctionOct 17, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE SEVERAL BD DAVOL CWS 400 HEMOVAC DRAINS FAILED TO MAINTAIN SUCTION POST-OPERATIVELY AT MERCY ONE DES MOINES. IN EARLY CASES, THE TUBING WAS FOUND TO BE TORN NEAR THE SUCTION AREA REQUIRING REPLACEMENT. MORE RECENTLY, DRAINS SHOWED REDUCED OUTPUT AND SITE BULGING DUE TO INTERNAL BLOOD CLOTS OBSTRUCTING FLOW. THESE ISSUES OCCURRED AFTER OR PLACEMENT AND DEVIATED FROM EXPECTED CONTINUOUS DRAINAGE PERFORMANCE. STAFF ARE NOW DOCUMENTING INCIDENTS, SAVING DEVICES WHEN POSSIBLE, AND ESCALATING CONCERNS FOR INVESTIGATION AND SUPPORT. THE EVENTS OCCURRED AFTER DEVICE PLACEMENT DURING POST-OPERATIVE MONITORING. NO PATIENT-IDENTIFIABLE INFORMATION IS AVAILABLE, BUT THE AFFECTED INDIVIDUALS WERE ADULT PATIENTS OF VARYING AGES AND GENDERS. NONE OF THE INCIDENTS RESULTED IN DEATH OR SERIOUS.

  Patient problems: Hematoma

  MAUDE report 23321666 ↗
• MalfunctionSep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THERE WAS A MATERIAL SPLIT, EVACUATOR WAS LEAKING, WOULD NOT HOLD SUCTION. PHOTOS WERE TAKEN BUT ACTUAL DEVICES WERE DISCARDED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096523 ↗
• MalfunctionSep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A MATERIAL SPLIT IN THE WOUND DRAIN, AND IT WAS LEAKING, WOULD NOT HOLD SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094929 ↗
• MalfunctionSep 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A MATERIAL SPLIT AND EVACUATOR WAS LEAKED, WONT HOLD SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083918 ↗
• MalfunctionJul 31, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE POST-SURGICAL UNITS HAVE REPORTED THAT THE DRAINS WERE CRACKING AT THE Y-SITE CONNECTION POINT. THIS ISSUE APPEARS TO BE ASSOCIATED WITH BARD ITEM 0043610, WHICH WAS RECENTLY ADOPTED AS PART OF A PRODUCT CONVERSION TO BD FOR PREMIER AD COMPLIANCE. A PHOTO HAS BEEN PROVIDED AS EVIDENCE, SHOWING VISIBLE DAMAGE AT THE Y-SITE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25JUL2025, IT WAS REPORTED THAT THE CUSTOMER WAS WORKING ON GETTING MORE INFORMATION FROM ANOTHER INCIDENT FROM YESTERDAY. THIS TIME IT DID NOT CRACK BUT THEY ARE REPORTING IT BROKEN AND A NEW ONE WAS PLACED BEDSIDE. THEY DID SEQUESTER IT SO MAYBE IF THEY CAN GET THE OR AND SURGICAL FLOOR STAFF TOGETHER TO FIGURE OUT WHAT WAS GOING ON, THEY COULD IDENTIFY A SOLUTION. THEY SAID THAT WHAT WAS HAPPENING MORE OFTEN THAT THE TUBE WAS DISCONNECTING FROM THE CONTAINER. THE CUSTOMER TALKED TO THE FLOOR AND HAD A PA THAT COULD PROBABLY HELP THE MOST, SO WAITED TO HEAR FROM THE PA. THE CUSTOMER THOUGHT IT WAS BEST TO GET WITH THE NEUROSURGERY PA AND THE FLOOR. AND, THE CUSTOMER HAD TO REALLY FIGURE OUT WHAT WAS HAPPENING BECAUSE THE CUSTOMER HEARD IT WAS BECAUSE OF RIGID TUBI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676008 ↗
• MalfunctionJul 31, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE POST-SURGICAL UNITS HAVE REPORTED THAT THE DRAINS WERE CRACKING AT THE Y-SITE CONNECTION POINT. THIS ISSUE APPEARS TO BE ASSOCIATED WITH BARD ITEM 0043610, WHICH WAS RECENTLY ADOPTED AS PART OF A PRODUCT CONVERSION TO BD FOR PREMIER AD COMPLIANCE. A PHOTO HAS BEEN PROVIDED AS EVIDENCE, SHOWING VISIBLE DAMAGE AT THE Y-SITE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25JUL2025, IT WAS REPORTED THAT THE CUSTOMER WAS WORKING ON GETTING MORE INFORMATION FROM ANOTHER INCIDENT FROM YESTERDAY. THIS TIME IT DID NOT CRACK BUT THEY ARE REPORTING IT BROKEN AND A NEW ONE WAS PLACED BEDSIDE. THEY DID SEQUESTER IT SO MAYBE IF THEY CAN GET THE OR AND SURGICAL FLOOR STAFF TOGETHER TO FIGURE OUT WHAT WAS GOING ON, THEY COULD IDENTIFY A SOLUTION. THEY SAID THAT WHAT WAS HAPPENING MORE OFTEN THAT THE TUBE WAS DISCONNECTING FROM THE CONTAINER. THE CUSTOMER TALKED TO THE FLOOR AND HAD A PA THAT COULD PROBABLY HELP THE MOST, SO WAITED TO HEAR FROM THE PA. THE CUSTOMER THOUGHT IT WAS BEST TO GET WITH THE NEUROSURGERY PA AND THE FLOOR. AND, THE CUSTOMER HAD TO REALLY FIGURE OUT WHAT WAS HAPPENING BECAUSE THE CUSTOMER HEARD IT WAS BECAUSE OF RIGID TUBI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676006 ↗
• MalfunctionJul 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE EVACUATOR WAS RECEIVED WITH A HAIR IN THE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437936 ↗
• MalfunctionJul 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE POST-SURGICAL UNITS HAVE REPORTED THAT THE DRAINS WERE CRACKING AT THE Y-SITE CONNECTION POINT. THIS ISSUE APPEARS TO BE ASSOCIATED WITH BARD ITEM 0043610, WHICH WAS RECENTLY ADOPTED AS PART OF A PRODUCT CONVERSION TO BD FOR PREMIER AD COMPLIANCE. A PHOTO HAS BEEN PROVIDED AS EVIDENCE, SHOWING VISIBLE DAMAGE AT THE Y-SITE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25JUL2025, IT WAS REPORTED THAT THE CUSTOMER WAS WORKING ON GETTING MORE INFORMATION FROM ANOTHER INCIDENT FROM YESTERDAY. THIS TIME IT DID NOT CRACK BUT THEY ARE REPORTING IT BROKEN AND A NEW ONE WAS PLACED BEDSIDE. THEY DID SEQUESTER IT SO MAYBE IF THEY CAN GET THE OR AND SURGICAL FLOOR STAFF TOGETHER TO FIGURE OUT WHAT WAS GOING ON, THEY COULD IDENTIFY A SOLUTION. THEY SAID THAT WHAT WAS HAPPENING MORE OFTEN THAT THE TUBE WAS DISCONNECTING FROM THE CONTAINER. THE CUSTOMER TALKED TO THE FLOOR AND HAD A PA THAT COULD PROBABLY HELP THE MOST, SO WAITED TO HEAR FROM THE PA. THE CUSTOMER THOUGHT IT WAS BEST TO GET WITH THE NEUROSURGERY PA AND THE FLOOR. AND THE CUSTOMER HAD TO REALLY FIGURE OUT WHAT WAS HAPPENING BECAUSE THE CUSTOMER HEARD IT WAS BECAUSE OF RIGID TUBIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396243 ↗
• InjuryNov 15, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DRAIN WAS PLACED ON A PATIENT IN (B)(6) 2023 IN OPERATING ROOM AND PULLED AT THE BEDSIDE BY THE PROVIDER TWO DAYS LATER. THE FOLLOWING DAY THE PATIENT HAD A CT SCAN, AND A 2 CM FOREIGN BODY WAS NOTED. THE PATIENT RETURNED TO OPERATING ROOM AND THE FOREIGN BODY WAS REMOVED IT WAS A DRAIN FRAGMENT. THE PROVIDER THAT PULLED THE DRAIN BELIEVED THE TUBING WAS INTACT WHEN THEY REMOVED IT, BUT THEY HAVE FOUND THROUGH THEIR ROOT CAUSE ANALYSIS PROCESS THAT THE TUBING OR DRAIN BROKE DURING THE REMOVAL OF THE DRAIN. THEY DID NOT HAVE THE ORIGINAL DRAIN OR TUBING OR THE DRAIN FRAGMENT BUT ATTACHED PICTURES OF THE SAME PRODUCT USED IN ITS PACKAGING AS WELL AS PICTURES OF THE DRAIN FRAGMENT TAKEN DURING THE RETURN TO OPERATING ROOM.

  Patient problems: Foreign Body In Patient

  MAUDE report 18139547 ↗
• MalfunctionApr 25, 2023Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE WOUND DRAIN TUBING WAS TOO FLEXIBLE AND THE POST OPERATION NURSE WERE HAVING ISSUES WHEN DISCONTINUING THEM. THEY BELIEVE THEY WERE NOT DRAINING CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809607 ↗
• MalfunctionNov 8, 2022Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE EVACUATOR BULB SUCTIONING FOR THE WOUND RECEIVED SIX WRONG LABELS. STATED THAT SIX 400ML EVACUATOR RECEIVED THEM AS A WRONG LABEL. THE AFFECTED EVACUATORS WERE (PCN# V0070740) AND (PCN# V0043610). PER CUSTOMER RESPONSE RECEIVED VIA MAIL ON 01NOV2022, IT WAS STATED THAT THE BARD WAS INCORRECTLY LABELED FOR V0043610 CWS 400 CLOSED WOUND SUCTION KITS. THE WRONG LABEL SAID IT WAS V0070740 -100CC SILICONE CLOSED WOUND SUCTION EVACUATOR W/REFLUX VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753095 ↗
• InjuryFeb 8, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT FEW DAYS BACK. IT WAS STATED THAT A HEMOVAC DRAIN WAS PLACED IN THE WOUND TO FACILITATE DRAINAGE AND ON THE DAY OF DRAINAGE, THE NURSE WENT TO REMOVE THE DRAIN AND MET SOME RESISTANCE BUT WAS ABLE TO PULL THE DRAIN. HOWEVER, UPON INSPECTION OF THE DRAIN POST REMOVAL IT WAS FOUND THAT THE DRAIN TO BE INCOMPLETE IN LENGTH AND AN X-RAY WAS TAKEN AND FOUND A PORTION OF THE DRAIN HAD BROKEN OFF INSIDE THE OPERATIVE SITE AND WAS RETAINED. STATED THAT AFTER A COUPLE OF DAYS, THE PATIENT WAS TAKEN BACK TO SURGERY FOR REMOVAL OF THE RETAINED PORTION. THE RETAINED DRAIN PIECE MEASURED 4 BY 0.2 BY 0.2 CM IN LENGTH. PATIENT WOULD BE MONITORED FOR POSSIBLE POST OPERATION INFECTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 13480845 ↗
• MalfunctionJun 23, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT HEMOVAC DRAIN SYSTEM DISCONNECTED WHEN THE PATIENT GOT OUT OF BED TO THE CHAIR. ALSO, CUSTOMER END UP TAPING THE ENDS OF THE PORT THAT WAS NOT CONNECTED TO THE HEMOVAC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054818 ↗
• MalfunctionApr 7, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THERE WAS DIFFERENCE IN SIZE OF TROCAR BETWEEN THE NOVAPLUS AND BRANDED PRODUCT. CUSTOMER HAD SOME CONCERNS AROUND ONE OF THE NOVAPLUS ITEMS ON MS1191. THE ITEM, V0043610, DID NOT APPEAR TO BE AN EXACT MATCH TO 0043610. THE NOVAPLUS ITEM WAS A 10 FR AND THE BRANDED ITEM WAS 9 FR. CUSTOMER ALSO REPORTED THAT THE TROCAR ON THE END OF THE BRANDED ITEM WAS MUCH SHARPER THAN THAT OF THE NOVAPLUS ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627681 ↗
• MalfunctionJan 13, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCARS WERE DULL.

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

  MAUDE report 11164347 ↗
• MalfunctionJan 13, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT TROCARS WERE DULL..

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

  MAUDE report 11164343 ↗
• MalfunctionJan 13, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCARS WERE DULL AND THE EVENT WAS OCCURRED ON (B)(6)020.

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

  MAUDE report 11164341 ↗
• MalfunctionJan 13, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCARS WERE DULL.

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

  MAUDE report 11164218 ↗
• MalfunctionDec 22, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PRODUCT WAS HOLDING AIR BUT TROCAR WAS DULL AND CUSTOMER HAD TO CUT FIRST TO PUT IN. PER FOLLOW UP RESPONSE RECEIVED ON (B)(6)2020, THE DEVICE WAS SUCTIONING AS INTENDED ONCE IT WAS PLACED. THE SKIN HAD TO BE CUT USING A BLADE IN ORDER TO GET THE DRAIN TUBING THROUGH. THE TROCAR WAS NOT SHARP ENOUGH TO PENETRATE THE SKIN. NO NEGATIVE IMPACT OTHER THAN A SMALL DELAY.

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

  MAUDE report 11059132 ↗
• MalfunctionDec 5, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCAR WAS DULL.

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

  MAUDE report 10951355 ↗
• MalfunctionNov 20, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCAR TIP WAS NOT SHARP.

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

  MAUDE report 10874029 ↗
• MalfunctionNov 19, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCAR WAS DULL.

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

  MAUDE report 10868355 ↗
• MalfunctionNov 19, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCAR WAS DULL.

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

  MAUDE report 10868150 ↗
• MalfunctionNov 19, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCAR WAS DULL.

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

  MAUDE report 10868149 ↗