ON-Q* Pain Relief System 13647Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193494136475), received between Aug 18, 2022 and Aug 18, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionAug 18, 2022Break; Break

  IT WAS REPORTED "THAT DURING THE REMOVAL OF THE CATHETER THE DISTAL END OF THE CATHETER WAS RETAINED IN THE PATIENT."(B)(6) THE CLINICIANS REMOVED BOTH CATHETERS, BOTH CATHETERS CAME OUT WITHOUT RESISTANCE, HOWEVER ONE OF THE CATHETERS DID NOT HAVE THE DISTAL BLACK TIP (THE OTHER DID). THERE ARE NO SIGNS OF PULLING ON THE CATHETER. "LEFT IN SITU DUE TO PATIENT CONDITIONS." THE CATHETER WAS SUTURED THROUGH.

  Patient problems: Foreign Body In Patient

  MAUDE report 15255094 ↗

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