Medline DYNJPI500CRecalls & reported problems
Medline Industries, Inc. · PRESSUREPLUS INFUSION BAG, 500ML · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10193489033113), received between Feb 12, 2026 and Sep 24, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (3 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
- Unintended Deflation3
- Decrease in Pressure1
- Deflation Problem1
- False Positive Result1
- Gas/Air Leak1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Deflation Problem
It was reported that "The bags are deflating with almost all product. Two hours is the usual time they are seeing the bag deflate."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882153 ↗MalfunctionSep 23, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873373 ↗MalfunctionSep 23, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872970 ↗MalfunctionSep 21, 2026Unintended Deflation
It was reported that "Discovered pressure bag on arterial line deflated when earlier it was verified at appropriate pressure/clamped (only 2 hours since it was checked)."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846475 ↗MalfunctionSep 9, 2026Gas/Air Leak
It was reported that "The bag was reported to be leaking air.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691703 ↗MalfunctionSep 1, 2026Unintended Deflation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548027 ↗InjuryFeb 12, 2026False Positive Result; Unintended Deflation
ACCORDING TO THE CUSTOMER, "THE PRESSURE BAG HAD DEFLATED" LEADING TO "FALSE DATA." THE CUSTOMER REPORTED THAT THE CLINICIAN BEGAN TREATING THE PATIENT FOR HYPOTENSION BY TITRATING "VASOPRESSORS BASED OFF OF THE ARTERIAL BP." PER THE CUSTOMER, "INVESTIGATION REVEALED THAT THE PRESSURE BAG HAD DEFLATED" AND THE "PRESSORS RAPIDLY TITRATED DOWN."
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 24326243 ↗
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 DYNJAAPI500SMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS6 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.