Medical Action Industries 74654Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10809160020388), received between Jun 2, 2023 and Jun 30, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 15, 2024Class IIOpen, Classified

   The kits contain saline flush syringes which were recalled by the supplier.

   Z-1394-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• InjuryJun 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MAI COMPLAINT NUMBER (B)(4). INCIDENT FIVE THE HUB IS NOT PROPERLY ATTACHING TO THE 7" EXT. TUBING. THIS OCCURRED WHILE CONNECTING TO PATIENT LINE RESULTING IN SOME PATIENT BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243762 ↗
• MalfunctionJun 2, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MAI COMPLAINT NUMBER (B)(4). INCIDENT ONE: ¿I'VE HAD IT HAPPEN ONCE DURING SET UP BEFORE IT REACHED THE PT. WHEN I ATTEMPTED TO ATTACH THE FLUSH TO THE HUB, THE TUBING CAME DETACHED FROM THE HUB AND FELL ON THE FLOOR BEFORE I EVEN TRIED TO FLUSH IT. I WAS LITERALLY JUST HANDLING THE EXTENSION SET WHEN IT FELL APART." THERE WAS NO PATIENT INVOLVEMENT FOR THIS INCIDENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17056546 ↗
• InjuryJun 2, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MAI COMPLAINT NUMBER (B)(4). INCIDENT THREE: "I WAS IN THE THIRD PATIENT'S ROOM. I WAS TEACHING (B)(6) HOW TO PLACE AN IV. IT'S ALMOST EXACTLY WHAT HAPPENED WITH THE SECOND PATIENT, EXCEPT THE HUB FELL OFF WHEN HAILEY WENT TO FLUSH IT. THE PATIENT STARTED BLEEDING, HAILEY CONTROLLED THE BLEEDING WHILE I GATHERED A NEW HUB AND FLUSHED. AGAIN I DON'T BELIEVE THERE WAS HARM TO THE PATIENT."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056529 ↗
• InjuryJun 2, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MAI COMPLAINT NUMBER (B)(4). INCIDENT FOUR THE HUB IS NOT PROPERLY ATTACHING TO THE 7" EXT. TUBING. INCIDENT OCCURRED WHILE ATTACHING CONNECTION TO PATIENT LEADING TO SOME PATIENT BLOOD LOSS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056527 ↗
• InjuryJun 2, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MAI 800002716, INCIDENT TWO. THE SECOND EVENT OCCURRED WITH A PATIENT. "I HAD SET UP AND PRIMED THE EXTENSION SET. I INSERTED THE IV, APPLIED MY TEGADERM, ATTACHED THE EXTENSION, AND WHEN I ATTEMPTED TO FLUSH, THE HUB FELL OFF WITH THE FLUSH AND FELL ON THE FLOOR. IT TOOK ME A SECOND TO FIGURE OUT WHAT HAPPENED AS MY SHIRT AND THE BED WERE STAINED IN BLOOD. IT WAS A HEALTHY ADULT PATIENT AND I DON'T BELIEVE THE PATIENT BLED ENOUGH TO CAUSE THEM HARM. A CO-WORKER WAS AT THE BEDSIDE WITH ME AND HELPED ME FIND A NEW HUB AND FLUSH WHILE I STOPPED THE BLEEDING."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050448 ↗
• InjuryJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MAI COMPLAINT NUMBER (B)(4). INCIDENT FIVE. THE HUB IS NOT PROPERLY ATTACHING TO THE 7" EXT. TUBING. THIS OCCURRED WHILE CONNECTING TO PATIENT LINE RESULTING IN SOME PATIENT BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050387 ↗