ON-Q* Pain Relief System 13603Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193494136031), received between Feb 3, 2022 and May 23, 2022 — classified as 2 malfunctions.

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

• MalfunctionMay 23, 2022Break; Break

  IT WAS REPORTED "THE PAINBUSTER CATHETER WAS CUT, LEAVING A 22CM-SIZED CATHETER IN THE PATIENT BODY, THEN REOPERATION PROCEEDED." ADDITIONAL INFORMATION RECEIVED 02-MAY-2022 STATING AFTER THE PATIENT'S MATERNAL CESAREAN SECTION, THE HEALTH CARE PROFESSIONAL PLACED THE CATHETER, AND THE NURSE REMOVED IT AFTER COMPLETING HER DRUG INJECTION. WHEN THE CATHETER BROKE AND IT REMAINED IN THE PATIENT'S BODY. A PROCEDURE WAS LATER PERFORMED TO RETRIEVE THE BROKEN CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 14474629 ↗
• MalfunctionFeb 3, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 115 ML, FLOW RATE: UNKNOWN , PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE/TIME WHEN INFUSION STARTED: (B)(6) 2021, DATE/TIME WHEN INFUSION ENDED: (B)(6) 2021. IT WAS REPORTED THAT ALL THE MEDICINE INFUSED IN 18-HOURS, EARLIER THAN EXPECTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13446417 ↗

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