Closed Wound Suction 0071430Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741049668), received between Aug 30, 2017 and Sep 3, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT CLINICAL TEAM WAS FINDING DEFECTS WITH THE WOUND DRAIN EVACUATOR KIT. 4 DRAINS, 2 DIFFERENT LOT¿S NGKP1782 AND NGKP4232.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952013 ↗
• MalfunctionAug 26, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ORIGINAL DRAIN DID NOT HAVE THE "WHITE PIECE" ATTACHED TO IT. CUSTOMER STATED THE PIECE THAT WAS FUSED ON THE DRAIN WAS KNOWN TO BREAK OFF IN THE PATIENT. CUSTOMER STATED THIS WAS AN INFERIOR SUBSTITUTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22895800 ↗
• MalfunctionAug 26, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT CLINICAL TEAM WAS FINDING DEFECTS WITH THE WOUND DRAIN EVACUATOR KIT. 4 DRAINS, 2 DIFFERENT LOT¿S NGKP1782 AND NGKP4232.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894690 ↗
• MalfunctionAug 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER HAVE A SECOND SET WITH THE SAME PLASTIC DEBRIS NOW, LOT# NGKP4232.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816310 ↗
• MalfunctionAug 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CUSTOMER FOUND SOME EXCESS PLASTIC ON THE TUBE OF AN INDIVIDUAL ITEM OF EVACUATOR. ON THE TUBING PORTION OF THE DRAIN THERE WERE SMALL PIECES OF PLASTIC THAT WERE ADHERED TO THE TUBING BUT SLOUGHED OFF EASILY. PRODUCT WAS DISCARDED; A NEW ONE WAS OPENED WITH NO ISSUES. SPOKE WITH CUSTOMER ABOUT THIS ISSUE AND ONLY FOUND ON A SINGLE ITEM SO FAR IN THE OR THAT DAY, THEY WERE GOING WITH MOST LIKELY A ONE OFF HOWEVER SINCE THEY COULD NOT CHECK THROUGH THE PACKAGING THE OR STAFF WILL BE INSTRUCTED TO INSPECT THE ITEM ONCE REMOVED FROM THE PACKAGING FOR DEBRIS, SET ASIDE THE PRODUCT, AND REPORT IT IF FOUND FOR FOLLOW UP. SAMPLE IS AVAILABLE AND WAS WITH THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772223 ↗
• InjuryJul 15, 2019Break; Break

  IT WAS REPORTED THAT WHEN THE DRAIN WAS BEING REMOVED POSTOPERATIVELY IT BROKE; THERE WERE PIECES LEFT INSIDE OF THE PATIENT RESULTING IN THE PATIENT HAVING TO GO BACK TO SURGERY. IT WAS ALSO REPORTED THAT THE DRAIN WAS INSERTED ON (B)(6) 2019 AND REMOVED ON (B)(6) 2019.

  Patient problems: Foreign Body In Patient

  MAUDE report 8788937 ↗
• InjuryAug 30, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT DOCTOR PLACED THE DRAIN IN THE PATIENT DURING CAROTID SURGERY. UPON REMOVAL OF THE DRAIN, A 2-1/2 PORTION BROKE OFF IN THE PATIENT. A STERILE CLAMP AND ULTRASOUND MACHINE WAS USED TO REMOVE THE PIECE. THE PATIENT WAS STABLE.

  Patient problems: No Information

  MAUDE report 6829468 ↗