ON-Q* C-Bloc with Dual SELECT-A-FLOW* 13477Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00193494134778), received between Jun 10, 2020 and Feb 4, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN , PROCEDURE: UNKNOWN , CATHPLACE: UNKNOWN. IT WAS REPORTED THERE WAS "EARLY TERMINATION OF THE HOMEPUMP INFUSER. IT WAS INSTALLED ON (B)(6) AT 4:55 P.M. AND WAS SCHEDULED TO END ON (B)(6) AT 3:00 P.M...THE MEDICATION ENDED ON (B)(6) AT AROUND 8PM. THE EARLY TERMINATION WOULD HAVE ALREADY HAPPENED IN THE PREVIOUS CYCLE, BUT WITH A SMALLER DIFFERENCE IN RELATION TO THE EXPECTED TIME (SAME BATCH)." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305765 ↗
• MalfunctionAug 6, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 750ML, FLOW RATE: 7 ML/HR, PROCEDURE: HYSTERECTOMY , CATHPLACE: UNKNOWN. IT WAS REPORTED, THE PATIENT HAD SURGERY ON THE MORNING OF (B)(6) 2024 AND WAS ADVISED THE PUMP WOULD LAST UNTIL (B)(6) 2024. THE PATIENT CALLED ON (B)(6) 2024 STATING THE PUMP WAS EMPTY. THE DEVICE WAS REMOVED. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 06-AUG-2024, THE PATIENT REPORTS FEELING "OUT OF IT" FOR 2-3 DAYS AND "HAD NO PAIN BUT FELT KIND OF HIGH." DENIES TINNITUS RELATED TO PUMP USE. DENIES METALLIC TASTE. THE PUMP WAS KEPT ON TOP OF A PILLOW AND WAS NOT COVERED. TUBING WAS TAPED DOWN APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923128 ↗
• MalfunctionJun 10, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2020-00094 FOR THE FIRST REPORT. REFER TO 2026095-2020-00096 FOR THE THIRD REPORT. FILL VOLUME: 600 ML. FLOW RATE: 10 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: (B)(6) 2019 TIME UNKNOWN. IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED; THE TOTAL INFUSION TIME WAS 50% FASTER THAN EXPECTED. INFUSION COMPLETED IN 40 HOURS INSTEAD OF THE EXPECTED 60 HOURS. PATIENT WAS RECEIVING LEVOBUPIVACAINE 0.125%. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10137818 ↗
• MalfunctionJun 10, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2020-00095 FOR THE SECOND REPORT. REFER TO 2026095-2020-00096 FOR THE THIRD REPORT. FILL VOLUME: 600 ML. FLOW RATE: 14 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: SUBCUTANEOUS, LATERAL TO EITHER SIDE OF THE STERNUM. INFUSION START TIME: (B)(6) 2019 1600. INFUSION STOP TIME: (B)(6) 2019 2200. IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED; THE TOTAL INFUSION TIME WAS 43% FASTER THAN EXPECTED. INFUSION COMPLETED IN 30 HOURS INSTEAD OF THE EXPECTED 42.5 HOURS. PATIENT WAS RECEIVING ROPIVACAINE 0.2%. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10137817 ↗
• MalfunctionJun 10, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2020-00094 FOR THE FIRST REPORT. REFER TO 2026095-2020-00095 FOR THE SECOND REPORT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED; THE TOTAL INFUSION TIME WAS 22% FASTER THAN EXPECTED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10137814 ↗

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