NA S1PIC1.9-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00858778006041), received between Jan 25, 2018 and Dec 18, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionDec 18, 2019Break

  RN WAS PREPARING DEVICE FOR PLACEMENT IN INFANT. AS RN WAS REMOVING PICC LINE FROM CLEAR PLASTIC BAG, LINE BROKE OFF FROM HEART SHAPED DISC ON CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9489368 ↗
• MalfunctionDec 4, 2019Leak/Splash; Leak/Splash

  DURING ASSESSMENT OF THE PICC, THE DRESSING APPEARED WET UNDERNEATH. MD WAS NOTIFIED AND PLACEMENT WAS VERIFIED. THE DRESSING WAS CHANGED AND THE PICC WAS NOTED TO BE LEAKING FROM THE PICC TUBING WHERE THE TUBING MEETS THE PLASTIC HEART. THE LINE WAS DISCONTINUED UPON DISCOVERY OF LEAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9413466 ↗
• InjuryApr 4, 2018Use of Device Problem; Use of Device Problem

  PICC LINE WAS PLACED IN LEFT BRACHIAL VEIN. SERIAL X-RAYS SHOWED TIP OF CATHETER IN THE RIGHT ATRIUM. AN ECHO SHOWED LARGE PERICARDIAL EFFUSION.

  Patient problems: Pericardial Effusion

  MAUDE report 7397715 ↗
• MalfunctionMar 15, 2018Break; Break

  REPORTEDLY, AS THE RN WAS COMPLETING THE DRESSING CHANGE, THE PICC LINE BROKE IN TWO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7343301 ↗
• MalfunctionJan 25, 2018Break

  RN WAS ATTEMPTING TO COMPLETE PICC LINE DRESSING CHANGE. AS RN WAS COMPLETING THE DRESSING CHANGE, THE LINE BROKE IN TWO. RN WAS ABLE TO REMOVE THE LINE IN ITS ENTIRETY. THE LINE WAS SECURED PER THE MANUFACTURER'S DIRECTION IN THEIR INSTRUCTIONS FOR USE. THE DEVICE HAS BEEN RETAINED AND WE WILL RETURN IT TO THE MANUFACTURER WHEN THEY CONTACT US.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7218422 ↗