Q2 Multiport Extension Set 9520Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00634624952003), received between Jun 7, 2016 and Mar 10, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. Jul 14, 2023Open, Classified

   For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

   Z-0197-2024 · Root cause: Material/Component Contamination · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO QUEST MEDICAL BY PROGRESSIVE MEDICAL OF AN ALLEGED ISSUE WITH PRODUCT CODE 9520. THE REPORT STATED THAT THE PORTS WERE CRACKING AND LEAKING WHEN OPENED. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524723 ↗
• MalfunctionJun 15, 2022Loss of or Failure to Bond; Loss of or Failure to Bond; Component Missing

  IT WAS REPORTED THAT THE MANIFOLD FOR THE MULTIPORT SET WAS MISSING THE TOP OF ONE OF THE PORTS. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14705359 ↗
• MalfunctionApr 7, 2022Loss of or Failure to Bond; Loss of or Failure to Bond; Break

  MEDWATCH (B)(4) WAS RECEIVED BY QUEST MEDICAL FROM (B)(6) MEDICAL. THE REPORT STATED THAT, DURING A CASE AT THE (B)(6) MEDICAL CENTER, A PATIENT BEGAN HAVING DECREASED OXYGEN SATURATION AND INCREASED HEART RATE AND RESPIRATIONS. IT WAS NOTED THAT THE PURPLE 6-PORT "MULTI-PORT" FLUID ADAPTER ALLEGEDLY HAD A BROKEN BLUE PORT, OPEN TO AIR.

  Patient problems: Arrhythmia; Increased Respiratory Rate; Low Oxygen Saturation; Tachycardia

  MAUDE report 14046650 ↗
• MalfunctionDec 13, 2016Air Leak

  THE PRODUCT DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED BY THE CLINICIAN WHILE USING THE INTRAVASCULAR ADMINISTRATION EXTENSION SET. THE REPORT DETAILS STATED THAT "AIR WAS ENTERING THRU DISTAL END OF MANIFOLD." FOLLOW-UP WITH THE COMPLAINANT FOUND THAT THERE WERE NO PATIENT COMPLICATIONS AND ANOTHER DEVICE WAS USED INSTEAD. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.``

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6169977 ↗
• MalfunctionJun 7, 2016Disconnection; Fluid/Blood Leak

  THE HOSPITAL RISK MANAGER REPORTED AN ISSUE ENCOUNTERED WITH THE DEVICE DURING USE. THE REPORT STATED THAT THE PATIENT HAD UNDERGONE A CORONARY ARTERY BYPASS AND WAS IN THE SURGICAL INTENSIVE CARE UNIT (SICU). TWO DAYS AFTER THE PROCEDURE THE NURSE CARING FOR THE PATIENT NOTICED THAT ONE PORT OF THE ADMINISTRATION MANIFOLD HAD COME OFF AND THAT MEDICATION WAS DRIPPING ONTO THE FLOOR. THE REPORT LISTED THE MEDICATION AS AMIODARONE. THE REPORT STATED THE NURSE CORRECTED THE PROBLEM. THERE WERE NO PATIENT OR PROVIDER COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5703466 ↗