NAMIC 91031303Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965910313030), received between Oct 6, 2017 and Nov 8, 2017 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANGIODYNAMICS WAS MADE AWARE OF THE EVENT REGARDING A CONTRAST INJECTION LINE VIA VOLUNTARY USER MEDWATCH # MW5072632: "PATIENT WAS HAVING CARDIAC ANGIOGRAM, ALL TUBING AND MEDRAD INJECTION WAS PRIMED AND BACKPRIMED. CONTRAST WAS INJECTED AND PATIENT STARTED TO LOSE BLOOD PRESSURE AND HEART RATE AND THEN CODED. THE PATIENT WAS TAKEN TO ICU. ON REVIEW OF THE CATH FILMS THE NEXT MORNING IT WAS DETERMINED THAT THE PATIENT HAD AN AIR EMBOLISM. THE TUBING THAT HAD BEEN USED DURING THE PROCEDURE HAD BEEN DISCARDED AND THE TEAM WAS NOT ABLE TO INSPECT FOR DAMAGE OR IF CONNECTIONS WERE SEALED AFTER CONTRAST HAD BEEN INJECTED THROUGH THE TUBING. THE INJECTOR WAS REMOVED FROM SERVICE AND CHECKED OUT AND FOUND TO BE WORKING PROPERLY."

  Patient problems: Air Embolism

  MAUDE report 7011256 ↗
• InjuryOct 6, 2017Adverse Event Without Identified Device or Use Problem

  PT WAS HAVING A CARDIAC ANGIOGRAM, ALL TUBING AND MED RAD INJECTOR WAS PRIMED AND BACK PRIMED. CONTRAST WAS INJECTED AND PT STARTED TO LOSE B/P AND HR AND THEN CODED. THE PATIENT WAS TAKEN TO ICU ON REVIEW OF THE CATH FILMS THE NEXT MORNING, IT WAS DETERMINED THAT THE PATIENT HAD AN AIR EMBOLISM. THE TUBING THAT HAD BEEN USED DURING THE PROCEDURE HAD BEEN DISCARDED AND THE TEAM WAS NOT ABLE TO INSPECT FOR DAMAGE OR IF CONNECTIONS WERE SEALED AFTER CONTRAST HAD BEEN INJECTED THROUGH THE TUBING. THE INJECTOR WAS REMOVED FROM SERVICE AND CHECKED OUT AND FOUND TO BE WORKING PROPERLY.

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension; No Code Available

  MAUDE report 6922097 ↗