ON-Q* C-Bloc with SELECT-A-FLOW* and ONDEMAND* 13473Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00193494134730), received between May 20, 2022 and Sep 11, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739508 ↗
• InjurySep 1, 2026Infusion or Flow Problem

  Patient problems: Pain

  MAUDE report 50543580 ↗
• InjuryAug 7, 2026Key or Button Unresponsive/not Working

  Fill Volume: Unknown.Flow Rate: Unknown. Procedure: Right tri-malleolar ankle open reduction andinternal fixation.CathPlace: Unknown.Date of procedure: (b)(6)2024.It was reported the patient was admitted for right tri-malleolar ankle open reduction and internal fixation surgery with a physician. Prior to the surgery, the patient was treated by anesthesiologists. The patient was recommended by the anesthesiologists to consent to the placement of a disposable pain pump ¿ "ON-Q Pain Relief System" ¿ to manage patient's post-operative pain.Prior to surgery, the physician performed the peripheral nerve block and catheter placement at the popliteal nerve on the patient's right leg. The placement of the block and catheter was done under ultrasound guidance. At the time of the placement of the block and catheter, the patient verbalized to the anesthesiologists of feeling a sharp sensation at the location of the block and catheter. A physician, who was overseeing the procedure, instructed the anesthesiologist to "back out" the needle /catheter when this occurred. These events were not reported or referenced in the patient's medical records. Following the procedure, patient was discharged ho

  Patient problems: Nerve Damage

  MAUDE report 50180741 ↗
• MalfunctionJul 27, 2026Physical Resistance/Sticking

  It was reported the "bolus button pops up immediately after pressing. Orange indicator is in the bottom location and not rising. Advised to close clamp on tubing. States anesthesiologist contact is not on his discharge instructions. Told to call hospital and request to talk to anesthesiologist on call." The patient did not want to call hospital because patient states they would not call patient back. Followed up with patient and patient confirmed calling hospital and was "waiting for a return call." There was no reported injury. Additional information received on 01-Jul-2026 stating the patient was able to get the pump replaced at the hospital and no longer has the device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50011883 ↗
• InjuryNov 1, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: 7 ML. PROCEDURE: ACL PROCEDURE. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2022. INFUSION STOP TIME: (B)(6) 2022. THE PATIENT REPORTED, 400 ML MEDICATION INFUSED QUICKER THAN EXPECTED; THEY HAD ON DEMAND SAF RUNNING AT 7 ML PER HOUR WITH ADDITIONAL 5 ML/HR ON DEMAND, THE PUMP WAS PLACED AT 230 PM ON (B)(6) 2022 AND WAS OUT BY 930 PM (B)(6) 2022. THE PATIENT REPORTED PUSHING THE BUTTON A MAXIMUM OF 10 TIMES, (PUSHED 4 TIMES WHILE IN THE HOSPITAL AND ABOUT 6 TIMES DURING THE AFTERNOON). CLIENT REPORTED IT MAY HAVE BEEN WARM AND POTENTIALLY SQUEEZED UNDER HER ARMPIT BECAUSE IT WAS BEING HELD IN HER BAG THAT WAY. THE PATIENT REPORTED THEY VOMITED A FEW TIMES; THERE WAS NO REPORT OF MEDICAL INTERVENTION; THEY ARE REPORTEDLY DOING OK. THE PATIENT WAS GUIDED THROUGH REMOVING THE DEVICE; THE BLACK TIP WAS REPORTEDLY INTACT.

  Patient problems: Vomiting

  MAUDE report 15712182 ↗
• MalfunctionMay 20, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 550 ML, FLOW RATE: 6ML/HR, PROCEDURE: ROTATOR CUFF, CATHPLACE: UNKNOWN, DATE OF PROCEDURE: 18-APR-2022. IT WAS REPORTED THE PUMP "INFUSED ENTIRE AMOUNT (550ML) IN A DAY AND A HALF." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 29-APR-2022 STATED THE "PATIENT DID NOT SUFFER ANY ADVERSE SIDE EFFECTS. NO SIGNS OR SYMPTOMS OF LOCAL ANESTHETIC TOXICITY. PATIENT IS CURRENTLY STABLE AND AT HOME RECOVERING FROM SURGERY PER EXPECTED OUTCOMES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462113 ↗

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