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PowerPICC SOLO CK000290BRecalls & reported problems

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

All models of PowerPICC SOLO (78)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741132070), received between Jun 8, 2017 and Nov 1, 2017 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 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

Device problems

  • Device Contamination with Chemical or Other Material2
  • Appropriate Device Problem Term/Code Not Available1
  • Material Deformation1

Patient problems

  • No Patient Involvement2
  • No Known Impact Or Consequence To Patient1
  • Numbness1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 1, 2017Material Deformation

    PER SALES REP, THE FACILITY REPORTED A DEFORMITY WITH MICRO-INTRODUCER TIP. IT WAS NOT USED ON PATIENT, NOTICED PRIOR TO PLACEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 6993722 ↗
  • MalfunctionSep 14, 2017Device Contamination with Chemical or Other Material

    IT WAS REPORTED BY THE SALES REP THAT THE FACILITY HAD A BROWNISH COLORED STICKY SUBSTANCE IN WITH THE PROBE COVERS. THE PROBE COVERS WERE NOT USED.

    Patient problems: No Patient Involvement

    MAUDE report 6866363 ↗
  • MalfunctionSep 14, 2017Device Contamination with Chemical or Other Material

    IT WAS REPORTED BY THE SALES REP THAT THE FACILITY HAD A BROWNISH COLORED STICKY SUBSTANCE IN WITH THE PROBE COVERS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6866006 ↗
  • InjuryJun 8, 2017Appropriate Device Problem Term/Code Not Available

    THE PATIENT REPORTED TO MEDICAL SERVICES & SUPPORT (MS&S) THAT HE HAD A POWER PICC INSERTED 15 DAYS AGO. HE REPORTED THAT HE EXPERIENCED NUMBNESS IN THE AREA OF THE LEFT ARM PICC THAT EXTENDED DOWN TO HIS MID FOREARM. THE PATIENT STATED THAT HE IS NOW AT HOME AND THE PICC WAS REMOVED 5 DAYS AGO AND HE IS STILL EXPERIENCING THE SAME NUMBNESS. HE EXPRESSED TO MS&S THAT HE WAS TOLD THE NUMBNESS WOULD IMPROVE AND IT HAS NOT IMPROVED. MS&S INFORMED THE PATIENT TO CONTACT HIS PHYSICIAN TO HAVE THE NUMBNESS IN HIS LEFT UPPER ARM AND FOREARM EVALUATED.

    Patient problems: Numbness

    MAUDE report 6624281 ↗

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Sources and updates

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