Port Access Needle SHG22-100YRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741089275), received between Feb 14, 2019 and Jun 27, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2019Leak/Splash

  ¿THE PATIENT PUT CHEMO IN A BAG AS IT WAS LEAKING FROM Y-SITE. FOUR HOURS LATER THE PATIENT CALLED A NURSE AND EXPLAINED IT HAD LEAKING EVERYWHERE. THE PATIENT DIDN'T GET FULL DOSE OF CHEMOTHERAPY.¿ THIS REPORT ADDRESSES THE SECOND SAMPLE RETURNED.

  Patient problems: Underdose

  MAUDE report 8740864 ↗
• MalfunctionMay 16, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT ¿THE PATIENT PUT CHEMO IN A BAG AS IT WAS LEAKING FROM Y-SITE. FOUR HOURS LATER THE PATIENT CALLED A NURSE AND EXPLAINED IT HAD LEAKING EVERYWHERE. THE PATIENT DIDN'T GET FULL DOSE OF CHEMOTHERAPY".

  Patient problems: Chemical Exposure

  MAUDE report 8617115 ↗
• MalfunctionApr 19, 2019Crack; Fluid/Blood Leak

  PATIENT CALLED ONCOLOGY TREATMENT CENTRE AS HER 5FU PUMP WAS LEAKING. PATIENT ADVISED TO CLAMP OFF AT THE IMPLANTED PORT, AND TO COME IN ASAP FOR REVIEW . ON ARRIVAL, PATIENT HAD PUT THE 5FU PUMP IN A PLASTIC BAG AND CLEARLY CHEMOTHERAPY WAS LEAKING QUITE A BIT IN THE BAG. PATIENTS SKIN WAS CLEANED WITH SALINE AND GAUZE NO SKIN DAMAGE. NO SIGNS OF REDNESS, SWELLING OR BURNING. REMOVED PUMP FROM THE IMPLANTED PORT, AND AS I FLUSHED THE PORT TO ASSESS, IT WAS LEAKING FROM A CRACK IN THE Y CONNECTOR OF THE EZ HUBER NEEDLE. IMPLANTED PORT DE-ACCESSED, AND RE-ACCESSED AGAIN. PORT FLUSHING, PATENT WITH GOOD BLOOD RETURN. 5FU PUMP REATTACHED. PATIENT ADVISED TO GO HOME AND SHOWER BODY, CLEAN TOWELS BEDLINEN CLOTHES AND ANY MATERIAL CONTACT WITH CHEMOTHERAPY IN A SEPARATE WASH ON A HIGH HEAT WITH BIOLOGICAL WASHING LIQUID AND TO CALL US IF SHE NOTICES ANY BURNING REDNESS OR SWELLING AROUND THE PORT A CATH SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8533558 ↗
• MalfunctionFeb 14, 2019Leak/Splash

  IT WAS REPORTED THAT THE EZ HUBER NEEDLE LEAKED AT THE Y-SITE ONTO THE PATIENT DURING THE ADMINISTRATION OF CHEMOTHERAPY.

  Patient problems: Chemical Exposure

  MAUDE report 8341214 ↗