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PowerPICC CK000209ARecalls & reported problems

Bard Access Systems, Inc. · Catheter Placement Kit · Class 2 · Implant

All models of PowerPICC (118)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741124150), received between Jun 16, 2017 and Jun 16, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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

Device problems

  • Detachment Of Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 16, 2017Detachment Of Device Component

    IT WAS REPORTED BY THE FACILITY VIA THE SALES REP THAT THE DL PICC WAS PLACED ON (B)(6) 2017. ON (B)(6) 2017 THE FACILITY REALIZED ONE OF THE LUMENS BROKE OFF WHERE IT MEETS THE PURPLE HUB WHILE IT WAS IN THE PATIENT. THEY HAD TO PLACE A NEW PICC. 06/06/2017 - ADDITIONAL INFORMATION RECEIVED VIA PAPERWORK FROM FACILITY/SALES REP. THE RED LUMEN WAS NOTED TO BE DETACHED FROM THE PICC LINE AND LYING IN THE PATIENT¿S BED, NO BLOOD PRESENT IN THE PATIENT¿S BED. THE HEALTHCARE PROFESSIONAL QUESTIONED IF THE LINE HAD ALREADY CLOTTED AND WALLED OFF. IT WAS NOTED THAT THE PATIENT HAD PULLED THE EXTENSION LEG OF THE PICC. THE LINE WAS INTACT APPROXIMATELY 3 HOURS PRIOR AND FLUSHED SUCCESSFULLY. THE PICC LINE WAS IMMEDIATELY REMOVED, IT WAS NOTED THAT 48 CM WAS OUT OF THE PATIENT AND 48CM REMAINED IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6648358 ↗

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Sources and updates

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