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Hickman 0601790Recalls & reported problems

Bard Access Systems, Inc. · External Catheter Segment for Hickman 10F Triple Lumen CV Catheters Repair Kit · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741036514), received between Nov 10, 2017 and Aug 22, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jan 4, 2023Open, Classified

    Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

    Z-1051-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Device Markings/Labelling Problem1
  • Difficult to Insert1
  • Fluid/Blood Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 22, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE INSTRUCTIONS WERE ALLEGEDLY MISSING FROM THE LABEL. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15264422 ↗
  • MalfunctionNov 10, 2017Fluid/Blood Leak; Difficult to Insert

    IT WAS REPORTED THAT THE CATHETER REPAIR BEGAN TO LEAK. IT WAS STATED BY THE FACILITY THAT THERE WAS DIFFICULTY INSERTING THE METAL PIN COMPLETELY INTO THE CATHETER DUE TO SOME POSSIBLE SILICONE RESIDUE. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7020159 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

All Catheter,intravascular,therapeutic,long-term greater than 30 days devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.