Port Access Needle 0631934Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741047527), received between Dec 1, 2024 and Dec 2, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

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.

• InjuryDec 2, 2024Break; Break

  IT WAS REPORTED BY MEDWATCH THAT PATIENT ADMITTED TO IN-PATIENT CARE (B)(6) 2024. RN CALLED TO PATIENT ROOM BY MOTHER AROUND 11:55 (B)(6) 2024. PER MOTHER, PATIENT WAS MOVING AROUND AND PAC NEEDLE BROKE RIGHT ABOUT Q-SYTE. STATLOCK WAS IN PLACE AT THIS TIME AND PAC NEEDLE TUBING WAS STILL SECURED IN PLACE EVEN AFTER Q-SYTE AND IV TUBING BROKE OFF. BLOOD SEEN BACKED UP INTO RESIDUAL PORT NEEDLE. RN CLAMPED PAC NEEDLE AND DE-ACCESSED PORT. APN MADE AWARE AND RN WILL HANG NEW BAG OF BLINA AT SAME RATE WHEN AVAILABLE FROM PHARMACY. CHEMO SPILL KIT WILL COME CLEAN ROOM SHORTLY. PATIENT'S PAC RE-ACCESSED AND NEW BLINATUMOMAB BAG HUNG. MOTHER WASHED PATIENT AND HERSELF WELL PER ADVICE FROM PHARMACIST. NO SKIN IRRITATION NOTED TO PATIENT'S SKIN. PATIENT PLAYING COMFORTABLY WITH MOTHER AT THIS TIME. APN UPDATED. NO NEW ORDERS AT THIS TIME. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION: COMPLICATED BY LINE INFECTION (B)(6). HAS PORT THAT WAS ABLE TO BE SPARED WITH ANTIBIOTICS AND INFECTION HAS BEEN TREATED. HAS PICC LINE PLACED (B)(6) FOR CHEMOTHERAPY USAGE, LINE WAS LOST (B)(6), NOW CHEMOTHERAPY HAS RETURNED TO BEING INFUSED VIA PORT. MEDWATCH STATES BLOOD CULTURE WAS POSITIVE W

  Patient problems: Bacterial Infection

  MAUDE report 20825387 ↗
• MalfunctionDec 1, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT (B)(6) 2024 HOMECARE PATIENT AS IN THE CARE WITH A FRIEND WHEN TUBING OF BUTTERFLY PAC CRACKED AT 16:45. PATIENT BROUGHT HOME PUMP AND TUBING TO HOSPITAL. TUBING CRACKED PROXIMAL TO Q-SYTE ON BUTTERFLY PAC TUBING. CLAMP OF PAC TUBING THEN FELL OFF AND PER PATIENT BLOOD WAS BACK FLOWING OUT OF LINE ONTO PATIENT. HOME BLINA BAG, TUBING, AND PUMP PLACED IN BIOHAZARD BAG BY ER. BAG BROUGHT TO THE FLOOR BY PATIENT. BAG CONTAINING HOME BLINA BAG, TUBING, AND PUMP DISCARDED DUE TO LARGE VOLUME OF CHEMOTHERAPY IN THE BAG. NEEDLE WAS LAST CHANGED IN CLINIC (B)(6) 2024. PATIENT WAS ON DAY (B)(6) 2024 OF INFUSION. PORT WAS DEACCESSED AND REACCESSED IN ED AND ADMITTED FOR RESTART OF INFUSION AND COORDINATION OF HOME SUPPLY. CHEMOTHERAPY WAS RESTARTED WITHIN 4 HOUR WINDOW SO NO CHANGE TO PATIENT'S TREATMENT. NO HARM TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20815478 ↗
• InjuryDec 1, 2024Break; Break

  IT WAS REPORTED BY MEDWATCH PATIENT BUTTERFLY PAC TUBING BROKE IMMEDIATE PROXIMAL TO Q-SITE WITH CONTINUOUS BLINATUMOMAB TRANSFUSION. CLAMP FELL OFF LINE AND BLOOD WAS BACK FLOWING FROM LINE. UNABLE TO FLUSH OR HEPARINIZE DUE TO CAP GETTING DISCONNECTED. PATIENT DE-ACCESSED AND RE-ACCESSED. THIS IS THE SECOND OCCURRENCE OF LINE SHEARING IN SAME LOCATION. CLASBSI ACA HELD 10/15 (INCIDENTALLY RIGHT AFTER THIS OCCURRENCE OF LINE SHEAR). MEDWATCH STATES BLOOD CULTURE WAS POSITIVE WITH KLEBSIELLA PNEUMONIA.

  Patient problems: Bacterial Infection

  MAUDE report 20815477 ↗
• MalfunctionDec 1, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT OUT-PATIENT CLIENT ADMITTED ON (B)(6) 2024 AT 13:30, PATIENT AT HOME WITH PAC IN PLACE WITH HOME INFUSION OF BLINATUMOMAB INFUSING TO PAC. HMH HOMECARE INFUSION OF BLINATUMOMAB TUBING SEVERED AT THE FILTER SITE. NURSE MANAGER NOTIFIED LINE CHANGED AND PATIENT WAS DISCHARGED. NO HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20815474 ↗
• MalfunctionDec 1, 2024Break; Break

  IT WAS REPORTED BY MEDWATCH THE PATIENT WAS ADMITTED TO IN-PATIENT HEATH CARE ON (B)(6) 2024 AT 23:05 PATIENT'S PAC LINE NOTED TO HAVE HOLE IN IT OVERNIGHT. BACKED UP BLOOD PER NIGHT SHIFT RN. BLINCY TO PAUSED. PAC REACCEDED. BLINCY TO RECONNECTED TO PATIENT'S NEW PAC. CHARGE NURSE AND PHYSICIAN NOTIFIED. NO ADDITIONAL INTERVENTION NEEDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20815472 ↗