PowerPICC Provena S1275108FD3Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741154959), received between Jun 19, 2020 and Mar 11, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC NURSE WAS CALLED IN TO LOOK AT A LEAKING PICC, ONE OF THE EXTENSION LEGS ON THE DUAL LUMEN WAS FRACTURED NEAR THE CLAMP. PICC WAS PLACED ON (B)(6) 2025. THE PICC WAS EXCHANGES FOR A MIDLINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580095 ↗
• MalfunctionMay 21, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THEY FOUND AN EYELASH FOUND IN A DL PICC KIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367239 ↗
• MalfunctionMar 29, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER, "REGARDING PICC INSERTION KITS THAT RECENTLY HAVE TRANSITIONED TO NEWER STYLE KITS WITH A DIFFERENT EXTENSION SET WITH THE WIRE EXTENDING THROUGH THE PORT. THE NEW STYLE T-PORT HAS A MORE CONCAVE STYLE IN WHICH THE WIRE FEEDS THROUGH.   AIR ENTERED THE CATHETER AT THE T-PORT INTO THE PICC AND PULLED BACK AIR AS THEY RETRACTED THE T-PORT SYRINGE. THE PICC WAS IMMEDIATELY REMOVED OR CLAMPED AND MANAGED WITHOUT PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16641014 ↗
• MalfunctionMar 26, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER, "REGARDING PICC INSERTION KITS THAT RECENTLY HAVE TRANSITIONED TO NEWER STYLE KITS WITH A DIFFERENT EXTENSION SET WITH THE WIRE EXTENDING THROUGH THE PORT. THE NEW STYLE T-PORT HAS A MORE CONCAVE STYLE IN WHICH THE WIRE FEEDS THROUGH.  AIR ENTERED THE CATHETER AT THE T-PORT INTO THE PICC AND PULLED BACK AIR AS THEY RETRACTED THE T-PORT SYRINGE. THE PICC WAS IMMEDIATELY REMOVED OR CLAMPED AND MANAGED WITHOUT PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616800 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE FACILITY EXPERIENCED CLASBI CASES WITH PICCS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10192308 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MS&S " SALES REP HAS AN ACCOUNT THAT HAS BEEN USING BD PICC (LOT REDV2129) AS A SUB FOR THEIR ROUTINE PICC LINE AND THEY ARE NOTICING AN INCREASE IN CLABSI CASES."

  Patient problems: Unspecified Infection

  MAUDE report 10175301 ↗