Port Access Needle SHG22-75YRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741089343), received between Feb 8, 2019 and Feb 14, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionFeb 14, 2019Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT HAD RECEIVED IV IMMUNOGLOBULINS AND PRE IV MEDICATIONS (RANTIDINE AND CHLORPHENAMINE) FOR 2.5 HOURS BEFORE THE LEAK WAS IDENTIFIED. CHEMOTHERAPY WAS BEING ADMINISTRATED FOR 45 MINS VIA AN INFUSION PUMP RUNNING AT 100MLS. FROM THE START OF THE INFUSION THE PUMP WAS INCREASED X 3 EVERY 15 MINS. THE PATIENT NOTICED THEIR CLOTHES WERE WET AND FLUID LEAKING FROM Y-SITE. IT WAS STATED INFUSION STOPPED AND EZ NEEDLE FLUSHED N/SALINE 0.9% THE NURSE DREW BACK BLOOD TO ENSURE NEEDLE WAS IN CORRECT POSITION ON THE PORT THE NEEDLE BLED BACK BUT LEAKED THOUGH THE Y SITE ON THE NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8341285 ↗
• MalfunctionFeb 8, 2019Leak/Splash

  IT WAS REPORTED THAT LEAKAGE FROM Y-SITE DURING INFUSION OF OBINUTUZUMAB 15 MINS AFTER THE 2ND INCREMENT I.E. 45 MINS INTO THE INFUSION. THE PATIENT HAS RECEIVED 50MLS/HR, AND WAS RUNNING AT 100MLS/HR. THE NURSE RETURNED TO THE PATIENT AS HE HAD CALLED HIS BUZZER TO SAY HIS SHIRT WAS WET AND THE PUMP WAS STOPPED. THE PATIENT HAD ALREADY RECEIVED IMMUNOGLOBULIN A VISCOUS FLUID AND THE PRE-MEDICATIONS FOR THE OBINUTUZUMAB WITH NO CONCERNS. THE CONNECTIONS ON THE TWO HUBS OF THE PORT WERE VYGON NEEDLE FREE CONNECTORS. THE PRESSURE DEFAULT ON THE PUMP IS SET AT 150 PSI NO AMENDMENTS WERE MADE TO THIS. THE CATHETER WAS FLUSHED WITH ONLY A SMALL AMOUNT OF SALINE TO ASCERTAIN WHERE THE LEAK WAS COMING FROM AND THIS WAS THE Y-SITE OF THE CONNECTION OF THE EZ HUBER, BLOOD COULD ALSO BE ASPIRATED BACK TO CONFIRM PATENCY BEFORE REMOVING. IT WAS STATED PATIENT TOP SLIGHTLY WET, NO LEAKAGE TO SKIN. PATIENT CHANGED INTO A HOSPITAL GOWN. INFUSION WAS STOPPED, HUBER SAFETY INFUSION SET CHANGED. THE PORT WAS DE-ACCESSED AND SAFETY DEVICE ACTIVATED AND THE PATIENT REASSESSED AGAIN FOR THE REST OF THE TREATMENT TO BE ADMINISTERED. THE ESTIMATED POTENTIAL MAXIMUM CALCULATED LOSS FOR OF THE MONOCLONAL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8322933 ↗