Halyard 13467Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651134674), received between Feb 5, 2019 and Feb 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K063530); they may or may not involve this specific model.

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.

• MalfunctionFeb 5, 2019Fluid/Blood Leak

  PAIN MANAGEMENT DECIDED TO SEND A PATIENT HOME WITH AN ON-Q PUMP. IT WAS DELIVERED TO THE FLOOR AND A FEW MINUTES LATER NURSING STAFF REPORTED TO PHARMACY THAT THE MEDICATION WAS SPRAYING EVERYWHERE FROM THE TUBING. THE FILTER ON THE TUBING WAS SPRAYING ROPIVACAINE EVERYWHERE. THE PHARMACIST LOOKED AT THE MANUFACTURES WEBSITE TO TRY AND FIND A REASON FOR THIS AND ASKED FELLOW PHARMACY COLLEAGUES IF THEY HAD EVER SEEN OR HEARD OF THIS HAPPENING AND THEY HADN'T. THE NEW BALL CAME UP IN ABOUT TWENTY MINUTES AND WITHIN THAT TIME THE OTHER PUMP HAD COMPLETELY DRAINED. LUCKILY, IT WAS IN THE SINK AND THE PATIENT HADN'T GONE HOME WITH THE FAULTY PRODUCT. THE NEW ONE WORKED LIKE IT SHOULD. THE FAULTY ON-Q PUMP WAS PLACED BACK IN ITS ORIGINAL PACKAGING JUST IN CASE IT WAS NEEDED FOR FOLLOW-UP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8304482 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063530. One submission often covers many models, so check the product and lot details in each record.

• Z-2860-2011 · Apr 15, 2011 · Terminated
  I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for p
• Z-2133-2008 · Feb 14, 2008 · Terminated
  On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narc
• Z-1869-2008 · Feb 12, 2008 · Terminated
  ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anest