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Manifold 193127Recalls & reported problems

Argon Medical Devices, Inc. · 3 Port Manifold - Right/Off/Block Body - 500 PSI · Class 2

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 00886333207060), received between Jun 4, 2020 and Jun 19, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (6 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

Device problems

  • Tear, Rip or Hole in Device Packaging6

Patient problems

  • No Known Impact Or Consequence To Patient4
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    THE ACCOUNT REPORTED A DEFECT IN THE PACKAGING. THIS WAS IDENTIFIED DURING THEIR INITIAL INSPECTION OF THE RECEIVED PRODUCT. THE DEVICE WAS NOT USED. NO PATIENT CONTACT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10174771 ↗
  • MalfunctionJun 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    THE ACCOUNT REPORTED A DEFECT IN THE PACKAGING. THIS WAS IDENTIFIED DURING THEIR INITIAL INSPECTION OF THE RECEIVED PRODUCT. THE DEVICE WAS NOT USED. NO PATIENT CONTACT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10174770 ↗
  • MalfunctionJun 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    THE ACCOUNT REPORTED A DEFECT IN THE PACKAGING. THIS WAS IDENTIFIED DURING THEIR INITIAL INSPECTION OF THE RECEIVED PRODUCT. THE DEVICE WAS NOT USED. NO PATIENT CONTACT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10174650 ↗
  • MalfunctionJun 19, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    THE ACCOUNT REPORTED A DEFECT IN THE PACKAGING. THIS WAS IDENTIFIED DURING THEIR INITIAL INSPECTION OF THE RECEIVED PRODUCT. THE DEVICE WAS NOT USED. NO PATIENT CONTACT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10174624 ↗
  • MalfunctionJun 4, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    THE ACCOUNT REPORTED A DEFECT IN THE PACKAGING. THIS WAS IDENTIFIED DURING THEIR INITIAL INSPECTION OF THE RECEIVED PRODUCT. THE DEVICE WAS NOT USED. NO PATIENT CONTACT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10119511 ↗
  • MalfunctionJun 4, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    THE ACCOUNT REPORTED A DEFECT IN THE PACKAGING. THIS WAS IDENTIFIED DURING THEIR INITIAL INSPECTION OF THE RECEIVED PRODUCT. THE DEVICE WAS NOT USED. NO PATIENT CONTACT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10119508 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.