AVANOS 44545Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00350770445458), received between Mar 19, 2020 and Jun 4, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 16, 2024Open, Classified

   MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

   Z-1186-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• InjuryJun 4, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED AND INCIDENT OCCURRED IN "PEJ (PERCUTANEOUS ENDOSCOPIC JEJUNAL) TUBE (DUAL) THAT IS INSERTED IN IR (INTERVENTIONAL RADIOLOGY) BURSTS INSIDE THE PATIENT, PEJ BLOCKED (NO MEDICATION WAS ADMINISTERED) AND UPON TRYING TO UNBLOCK, IT BURST INSIDE THE PATIENT'S BODY, CAUSING HIM TO HAVE A HEMATOMA." THE PATIENT EXPERIENCED PHYSICAL PAIN AND STOMACH CONTENT IN ABDOMINAL CAVITY WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 14-MAY-2024, "INTERVENTIONAL RADIOLOGY FOR TUBES CHANGES (PERCUTANEOUS GASTROTOMY, TUBE VERIFICATIONS IN ANGIO)."

  Patient problems: Hematoma; Pain

  MAUDE report 19461892 ↗
• MalfunctionApr 26, 2023Misconnection; Misconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2023-00057 FOR THE FIRST REPORT. FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT (B)(4) REPORTED, WE HAVE HAD TWO INSTANCES OF PATIENTS WITH GASTRIC-JEJUNAI TUBES IN PLACE THAT HAVE BEEN FED/RECEIVED MEDICATIONS INTO THE WRONG LOCATION DUE TO CHANGES IN THE PRODUCT. THE PRODUCT PREVIOUSLY HAD THE JEJUNAL PORT AS THE STRAIGHT PORT AND THE GASTRIC PORT AS THE SIDE PORT. IN A RECENT CHANGE BY THE MANUFACTURER, THE PORT LOCATIONS HAVE BEEN SWAPPED. THIS CHANGE HAS BEEN FURTHER COMPLICATED BY THE RUBBING OFF OF THE TEXT THAT LABELS THE PORTS AS EITHER GASTRIC OR JEJUNAI.

  Patient problems: Insufficient Information

  MAUDE report 16815527 ↗
• MalfunctionApr 26, 2023Misconnection; Misconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2023-00058 FOR THE SECOND REPORT. FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT MW5115942 REPORTED, ¿WE HAVE HAD TWO INSTANCES OF PATIENTS WITH GASTRIC-JEJUNA! TUBES IN PLACE THAT HAVE BEEN FED/RECEIVED MEDICATIONS INTO THE WRONG LOCATION DUE TO CHANGES IN THE PRODUCT. THE PRODUCT PREVIOUSLY HAD THE JEJUNAL PORT AS THE STRAIGHT PORT AND THE GASTRIC PORT AS THE SIDE PORT. IN A RECENT CHANGE BY THE MANUFACTURER, THE PORT LOCATIONS HAVE BEEN SWAPPED. THIS CHANGE HAS BEEN FURTHER COMPLICATED BY THE RUBBING OFF OF THE TEXT THAT LABELS THE PORTS AS EITHER GASTRIC OR JEJUNAI.

  Patient problems: Insufficient Information

  MAUDE report 16815514 ↗
• MalfunctionMay 20, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2022-00067 FOR THE SECOND EVENT. REFER TO 9611594-2022-00068 FOR THE THIRD EVENT. IT WAS REPORTED THERE WAS AN ISSUE WHERE THE LABEL WAS RUBBING OFF OF THE G-J TUBE(IE: GASTRIC AND JEJUNAL LABELS RUBBING OFF ACTUAL TUBING). THERE WAS A REPORT OF MEDICATIONS BEING PUT DOWN THE WRONG PORT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 28-APR-2022 STATING IT WAS REPORTED BY NURSING THAT THE LABEL RUBBED OFF SOONER THAN THIS AND TAPE WAS PUT ON TO HELP IDENTIFY THE TUBES, THE DATE OF EXACT RUBBING OFF IS UNKNOWN. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14453998 ↗
• MalfunctionMay 20, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2022-00066 FOR THE FIRST EVENT. REFER TO 9611594-2022-00068 FOR THE THIRD EVENT. IT WAS REPORTED THERE WAS AN ISSUE WHERE THE LABEL WAS RUBBING OFF OF THE G-J TUBE (IE: GASTRIC AND JEJUNAL LABELS RUBBING OFF ACTUAL TUBING). THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 28-APR-2022 STATING IT WAS REPORTED BY NURSING THAT THE LABEL RUBBED OFF SOONER THAN THIS AND TAPE WAS PUT ON TO HELP IDENTIFY THE TUBES, THE DATE OF EXACT RUBBING OFF IS UNKNOWN. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14453926 ↗
• MalfunctionMay 20, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2022-00066 FOR THE FIRST EVENT. REFER TO 9611594-2022-00067 FOR THE SECOND EVENT. IT WAS REPORTED THERE WAS AN ISSUE WHERE THE LABEL WAS RUBBING OFF OF THE G-J TUBE (IE: GASTRIC AND JEJUNAL LABELS RUBBING OFF ACTUAL TUBING). THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 28-APR-2022 STATING IT WAS REPORTED BY NURSING THAT THE LABEL RUBBED OFF SOONER THAN THIS AND TAPE WAS PUT ON TO HELP IDENTIFY THE TUBES, THE DATE OF EXACT RUBBING OFF IS UNKNOWN. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14453672 ↗
• InjuryMar 19, 2020Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW5092841 RECEIVED ON 24-FEB-2020, AND THE FOLLOWING INFORMATION WAS PROVIDED: EVENT INVOLVES PROBLEM WITH MIC-GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTORS-ENDOSCOPIC/RADIOGRAPHIC PLACEMENT. THIS REPORT IS EXAMPLE OF COMPLICATIONS ARISING FROM RISK OF ENFIT PRODUCTS BECOMING STUCK. PT ADMITTED TO THE PICU POST TPIAT WITH A CRITICAL GJ TUBE OVER THE COURSE OF HER ADMISSION IN THE PACU, THE J PORT OF THE GJ TUBE BECAME STUCK IN EFFORTS TO REMOVE, THE J PORT FEMALE ADAPTER WAS DISLODGED AND SUBSEQUENTLY DISCARDED THE INTEGRITY OF THE TUBE WAS COMPROMISED, BUT GIVEN THE CRITICAL NATURE OF THE TUBE AND THE FRESH ABDOMINAL SURGERY, THE PT WAS NOT A CANDIDATE FOR REPLACEMENT AT THAT TIME. CONNECTION BETWEEN THE FEED BAG AND THE J PORT WERE MAINTAINED WITH THE USE OF AN AMT CLAMP. PT TRANSFERRED TO THE FLOOR SEVERAL DAYS LATER. THE AMT CLAMP SYSTEM PROVED TO BE INEFFECTIVE FOR LONG-TERM MANAGEMENT AND NEEDED TO BE REPLACED MULTIPLE TIMES. EVENTUALLY, THE J PORT RIPPED, MAKING IT IMPOSSIBLE TO SECURE THE FEEDING BAG CONNECTION, RESULTING IN THE LOSS OF ENTERAL PRODUCTS. THIS LED TO SEVERE HYPOGLYCEMIA AND THE PT NEEDED

  Patient problems: Adult Respiratory Distress Syndrome; Hypoglycemia; No Code Available

  MAUDE report 9857998 ↗