ON-Q* C-Bloc Pain Relief System with ONDEMAND 13471Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193494134716), received between Sep 3, 2021 and Sep 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2023-00094 FOR THE FIRST EVENT. REFER TO 2026095-2023-00095 FOR THE SECOND EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE "ON-DEMAND BUTTON DID NOT RESET AND REMAINED IN THE DOWN POSITION." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17698642 ↗
• MalfunctionSep 7, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2023-00094 FOR THE FIRST EVENT. REFER TO 2026095-2023-00096 FOR THE THIRD EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE "ON-DEMAND BUTTON DID NOT RESET AND REMAINED IN THE DOWN POSITION." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17698632 ↗
• MalfunctionSep 7, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED 06-SEP-2023 STATING THE "BOLUS BUTTON REMAINED DEPRESSED FOR 39 MINUTES. DECISION MADE TO DISCONTINUE ON Q PUMP AND HAVE PATIENT USE AN AMBIT PUMP. NO PATIENT HARM REPORTED. NO SIGNS AND SYMPTOMS OF LIDOCAINE TOXICITY REPORTED."

  Patient problems: Insufficient Information

  MAUDE report 17698631 ↗
• MalfunctionSep 3, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 550 ML FLOW RATE: 5 ML/HR PROCEDURE: ACL REPAIR CATHPLACE: NERVE BLOCK INFUSION START TIME: (B)(6) 2021 10:00AM INFUSION STOP TIME: (B)(6) 2021 09:00AM. IT WAS REPORTED THAT THE DEVICE "DELIVERED IN 48 HOURS WHEN THEY USUALLY LAST MINIMUM 3 DAYS (DEPENDING ON BOLUS USAGE), THEY OVER FILL THE PUMP TO THE 550ML MAXIMUM. NO ADVERSE REACTION TO PATIENT AND THEY NOTED THAT THEIR PAIN WAS MINIMAL, SO PUMP WAS DEFINITELY WORKING JUST DELIVERED TOO FAST. THE PATIENT WENT HOME WITH THE PUMP DAY OF SURGERY (ACL REPAIR) AND HAS REMOVED CATHETER AND DISCARDED THE PUMP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422152 ↗

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