ON-Q* C-Bloc Pain Relief System 31614Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193494316143), received between Dec 8, 2020 and Aug 14, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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.

• MalfunctionAug 14, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 400ML. FLOW RATE: 7ML/HR. PROCEDURE: ABDOMINOPLASTY. CATHPLACE: ABDOMEN. START TIME: 12:00PM, 17-JUL-2024. STOP TIME: 8:00PM, 17-JUL-2024. IT WAS REPORTED, "PUMP WAS PLACED IN AM WITH FILL VOLUME OF 400 ML, SET AT 7ML/HR, AND THE PUMP INFUSED COMPLETELY BY 8PM." ADDITIONAL INFORMATION RECEIVED 24-JUL-2024 STATED THE PUMP WAS ABOVE THE CATHETER, 6 INCHES (DISTANCE BETWEEN THE PUMP AND CATHETER). THE TUBING WAS UNDER THE PATIENT'S CLOTHING AND/OR BLANKET. THERE WERE NO AIR BUBBLES NOTED AND THE ENVIRONMENTAL ROOM TEMPERATURE WAS 72-DEGREE FAHRENHEIT. THE PATIENT DESCRIBED AN INTENSE BURNING SENSATION IN ABDOMEN FOLLOWED BY NUMBNESS. THE DEVICE WAS USED IN THE PATIENT'S HOME SETTING. PATIENT NOTED EXCESSIVE SWELLING/ LEAKAGE AND REQUESTED AN APPOINTMENT THE FOLLOWING DAY. IT WAS NOTED THERE WERE 30-MINUTES BETWEEN FILLING AND USE OF THE DEVICE. THE PATIENT RECEIVED WRITTEN AND ORAL INSTRUCTIONS ON USE OF THE DEVICE. THERE WERE NO CHANGES IN THE FLOW RATE DURING THERAPY.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19986129 ↗
• MalfunctionDec 8, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML. FLOW RATE: 2 ML/HR. PROCEDURE: BILATERAL MASTECTOMY. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2020. INFUSION STOP TIME: UNKNOWN. FDA MEDWATCH / FDA USER FACILITY REPORT # MW5097398 RECEIVED ON 16-NOV-2020, AND THE FOLLOWING INFORMATION WAS PROVIDED: "PATIENT UNDERWENT BILATERAL MASTECTOMY ON (DATE REDACTED) 2020. TWO ON-Q PUMPS PLACED, ONE WHICH MALFUNCTIONED AND INFUSED ALL OF THE DRUG OVER A SHORTER PERIOD OF TIME THAN INTENDED. IT WAS A 550ML PUMP FILLED WITH 400ML ROPIVACAINE 0.5%, DUAL CATHETER, FLOW RATE 2ML/HR THROUGH EACH CATHETER. PUMP REMOVED FROM PATIENT ON UNKNOWN DATE." NO PATIENT INJURY OR ADVERSE EFFECTS WERE NOTED. ADDITIONAL INFORMATION RECEIVED 17-NOV-2020 INDICATED THE PROCEDURE DATE AND START DATE OF THE INFUSION WAS (B)(6) 2020. THE PUMP WAS FILLED TO 400ML. ADDITIONAL INFORMATION RECEIVED 18-NOV-2020 INDICATED THE EVENT OCCURRED AFTER THE PATIENT LEFT THE HOSPITAL AND NO FURTHER INFORMATION WAS AVAILABLE IN THE HOSPITAL RECORD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10967971 ↗

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