PowerPICC CK000758Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741141140), received between Apr 16, 2021 and Apr 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "ON PICC LINE PLACEMENT, VAS SPECIALIST WAS UNABLE TO GET THE YELLOW WAVEFORM INTRATHORACIC VISABLE ON THE PICC MONITOR. USUAL SUSPECTS WERE CHECKED. SPECIALIST TOOK THE STYLET OUT OF THE PICC AND RECALIBRATED AND THEN REINSERTED THE STYLET INTO THE PICC LINE. AT THIS TIME DURING THE PROCEDURE, THE VAS SPECIALIST NOTICED APPROXIMATELY 4 CM OF THE TIP OF THE STYLET WAS HANGING LOOSE AND WHEN THIS AREA WAS TOUCHED IT BROKE COMPLETELY OFF OF THE END OF THE STYLET. " ADDITIONAL INFORMATION RECEIVED 04/02/2021: PER SPECIALIST: STARTED OUT STANDARD PROCEDURE BUT NOTICED HE DID NOT GET A NORMAL WAIVE FORM. CHECKED CONNECTIONS, FLUSHED CATHETER AGAIN AND WITH NO LUCK HE THEN PULLED THE WIRE BACK COMPLETELY BACK TO RECALIBRATE. AT THAT POINT HE COULD SEE THE TIP OF THE WIRE, NOTICED SOMETHING DID NOT LOOK RIGHT SO WHEN HE TOUCHED THE WIRE TO LOOK CLOSER, HE NOTICED APPROX. 4 CM¿S HANGING OFF OF STYLET. WIRE WAS BROKE. WAS THERE PATIENT HARM REPORTED?: NO BECAUSE WIRE BROKE OUTSIDE OF PT. THEY DID X-RAY JUST TO MAKE CERTAIN AND SHOWED NO SIGNS OF THE WIRE IN THE PT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680374 ↗