Medline DYNJAAPI500SRecalls & reported problems
Medline Industries, Inc. · 500ML,PRESSURE INFUSER W/STOPCOCK · Class 1
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10080196759699), received between Dec 11, 2025 and Sep 29, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (5 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
Most reported problems
Device problems
- Gas/Air Leak5
- Decrease in Pressure1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938846 ↗MalfunctionSep 22, 2026Gas/Air Leak
It was reported that Medline 500ml pressure bag with stopcock valve, not effectively holding air despite stop cock being in the correct "off" position. The pressure bag is slowly losing air over time requiring nurse to frequently reinflate and check on pressure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853369 ↗MalfunctionSep 22, 2026Gas/Air Leak
It was reported that "the new pressure infusor bags 1000ml size from Medline are not holding pressure, and are slowly leaking air during cases."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852788 ↗MalfunctionSep 21, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841035 ↗MalfunctionSep 21, 2026Gas/Air Leak
It was reported that "The clinicians and staff have reported that we are having problems holding pressure in one of our products we get from MEDLINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840923 ↗MalfunctionDec 11, 2025Decrease in Pressure; Decrease in Pressure
ACCORDING TO THE CUSTOMER CONTACT, "THE PRESSURE BAG DOES NOT HOLD PRESSURE, EVEN WITH DEAD ENDER CAP ON AIR INTAKE VALVE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23780219 ↗
Other INFUSOR, PRESSURE, FOR I.V. BAGS devices
- Medex MX4705Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS36 reports
- InfuseIT ZIT-520Salter Labs · INFUSOR, PRESSURE, FOR I.V. BAGS19 reports
- Medex MX4810Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS15 reports
- Medline DYNJAAPI1000SMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS1 death9 reports
- Medex MX4805Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS9 reports
- Medline DYNJPI500CMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS7 reports
- Vital Signs IN800048Hygia Health Services, Inc. · Infusor, Pressure, For I.V. Bags3 reports
- Vital Signs™ IN800012Airlife · INFUSOR, PRESSURE, FOR I.V. BAGS3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.