PowerPICC Catheter 3175155Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741027680), received between Aug 11, 2021 and Dec 29, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. May 19, 2021Terminated

   Catheter kits contained the incorrect micro-introducers.

   Z-1991-2021 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionDec 29, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT OUR IR DEPARTMENT HAS REPORTED AN ISSUE WITH BARD STOCK# (B)(4). THE IR DEPARTMENT REPORTS LEAKING AT THE HUB. THIS HAS OCCURRED ON TWO SEPARATE OCCASIONS WITH BOTH PRODUCTS HAVING THE SAME LOT#. PICC NURSE WAS HAVING TROUBLE SO HE CAME TO US IN IR. FIRST ONE PLACED 12/4 HAD SLOW DRIPPING LEAK AT HUB (AFTER MULTIPLE REPLACEMENTS) AND WE REPLACED IT YESTERDAY 12/5 AND NOW THAT ONE APPEARS TO BE HAVING THE SAME ISSUES. PICC RN BROUGHT US ONE OF THEIR KITS. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18421923 ↗
• MalfunctionDec 29, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT OUR IR DEPARTMENT HAS REPORTED AN ISSUE WITH BARD STOCK# 3175155. THE IR DEPARTMENT REPORTS LEAKING AT THE HUB. THIS HAS OCCURRED ON TWO SEPARATE OCCASIONS WITH BOTH PRODUCTS HAVING THE SAME LOT#. PICC NURSE WAS HAVING TROUBLE SO HE CAME TO US IN IR. FIRST ONE PLACED 12/4 HAD SLOW DRIPPING LEAK AT HUB (AFTER MULTIPLE REPLACEMENTS) AND WE REPLACED IT YESTERDAY 12/5 AND NOW THAT ONE APPEARS TO BE HAVING THE SAME ISSUES. PICC RN BROUGHT US ONE OF THEIR KITS. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18421922 ↗
• MalfunctionAug 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA HEALTH CANADA¿S MEDICAL DEVICES ONLINE DATABASE: "E2003 - CHEMICAL EXPOSUREF26 - NO HEALTH CONSEQUENCES OR IMPACTA050401 - FLUID LEAK." ADDITIONAL INFORMATION RECEIVED:: DURING PATIENT¿S CHEMOTHERAPY INFUSION, THE PICC LINE LEAKED (AT POINT WHERE CAP SCREWS ONTO LUMEN). THE INFUSION WAS STOPPED; A SMALL, WET SPOT ON PATIENT¿S ARM WAS WASHED AND DRIED. CHEMOTHERAPY LINE WAS CAPPED AND REMOVED. WHEN THE PICC WAS FLUSHED, LEAKAGE WAS NOTED FROM THE SALINE CAP CONNECTION. CAP WAS REMOVED AND A NEW ONE PLACED; SAME LEAKAGE OCCURRED. CAP WAS REMOVED AND FLUSHED WITH SALINE DIRECTLY; NO LEAKAGE OCCURRED. A SMALL BUMP NEAR THE END OF THE PICC LUMEN WAS NOTED. INTERVENTIONAL RADIOLOGY (IR) NOTIFIED; IR NURSE ADDED EXTENSION TUBING AS A TEMPORARY FIX. WRITER USED PERIPHERAL IV SITE TO CONTINUE CHEMO TREATMENT. PICC WAS EXCHANGED.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310115 ↗
• MalfunctionAug 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA HEALTH (B)(6) MEDICAL DEVICES ONLINE DATABASE: (B)(4. NO OTHER INFORMATION REGARDING THE EVENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309951 ↗