ON-Q* Pain Relief System 13649Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193494136499), received between Mar 9, 2021 and Mar 9, 2021 — 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.

• MalfunctionMar 9, 2021Break; Break

  IT WAS REPORTED THAT A NURSE MANAGER ATTEMPTED TO REMOVE TWO CATHETERS FROM THE PATIENT'S ABDOMINAL INCISION SITE ON POST-OP DAY 5. INITIALLY THERE WAS SOME RESISTANCE AND ONLY ONE CATHETER COULD BE REMOVED. THE SECOND CATHETER BROKE OFF WHILE REMOVING AND APPROXIMATELY 5.8CM WAS LEFT IN THE PATIENT. ACCORDING TO THE DISTRIBUTOR, THE "PATIENT HAD NO DISCOMFORT" AND THE PHYSICIAN RESPONDED "THAT THERE IS NO NEED TO REMOVE THE CATHETER AS IT CAUSES NO HARM TO THE PATIENT." ADDITIONAL INFORMATION RECEIVED 01-MAR-2021 INDICATED THE PATIENT'S CURRENT STATUS WAS "NO ISSUE." BUPIVACAINE WAS INFUSED THROUGH THE CATHETER AND THE PRODUCT WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. PRIOR TO USE, THE PRODUCT HAD BEEN STORED IN "OPERATING THEATRE CONDITIONS." THE CATHETER WAS PLACED VIA A TUNNELLER AND IT WAS NOT SUTURED THROUGH.

  Patient problems: Foreign Body In Patient

  MAUDE report 11448591 ↗

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