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NAMIC 90701482 (UDI H965907014820)Recalls & reported problems

Navilyst Medical, Inc. · PRESSURE MONITORING LINE 48" · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965907014820), received between Aug 16, 2019 and Aug 16, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

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

  • Crack1
  • Fluid/Blood Leak1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 16, 2019Crack; Fluid/Blood Leak

    PATIENT'S A-LINE WAS NOT TRANSDUCING. THE NURSE USED PAPAVERINE, AS WELL AS FLUSHING AND REPOSITIONING WHICH DID NOT RESOLVE THE PROBLEM. WHILE INSTILLING THE PAPAVERINE INTO THE TUBING, A CRACK WAS DISCOVERED IN THE NAMIC PRESSURE MONITORING LINE TUBING AT THE CONNECTION POINT WITH THE PAPAVERINE SYRINGE AND A SMALL PUDDLE HAD FORMED ON THE SYRINGE PUMP. THE TUBING WAS CHANGED, AND THE LEAKING WAS RESOLVED. TWO DAYS LATER, A CRACK WAS FOUND IN A SECOND NAMIC PRESSURE MONITORING TUBING AT THE CONNECTION POINT WITH THE SYRINGE AND A PUDDLE FORMED ON THE SYRINGE PUMP. IN THIS CASE, A POOR TRACING WAS NOTED AND WAS RESOLVED WHEN THE TUBING WAS CHANGED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8900834 ↗

Other MONITOR, LINE ISOLATION devices

All MONITOR, LINE ISOLATION devices →

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