ON-Q* Pain Relief System with SELECT-A-FLOW* 13476Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00193494134761), received between Jan 29, 2021 and Jul 14, 2026 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Fracture; Material Separation

  Patient problems: Foreign Body In Patient

  MAUDE report 25811911 ↗
• MalfunctionJul 2, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN FLOW RATE: UNKNOWN PROCEDURE: STATUS POST TOTAL KNEE REPLACEMENT CATHPLACE: ABDUCTOR CANAL. IT WAS REPORTED, FACILITY EXPERIENCED FAST FLOW WITH ELASTOMERIC PUMP, THE PUMP EMPTIED IN LESS THAN 24-HOURS. THE PHYSICIAN IS NOT AWARE OF HOW MUCH FLUID WAS PLACED IN THE PUMP BEFORE STARTING THE INFUSION. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT HAD NO COMPLAINTS OF PAIN; AFTER EVALUATION FROM ANESTHESIA, THE PHYSICIAN PLACED A DIFFERENT PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384200 ↗
• MalfunctionApr 22, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 600ML, FLOW RATE: (2-14ML), PROCEDURE: ROTATOR CUFF, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP WAS EMPTY. THE PATIENT WAS IN PAIN AND WAS TOLD THE PUMP WOULD LAST 60 MORE HOURS. THE ESTIMATED TIME PUMP WAS STARTED WAS FRIDAY, ON (B)(6) 2025, AT 0900 PUMP AT 10ML/HR. THE ESTIMATED TIME PUMP FINISHED WAS SUNDAY, ON (B)(6) 2025, AT NOON. THE PATIENT AND PATIENT'S SPOUSE VERBALIZED THEY DID NOT CHANGE THE RATE AT ANY POINT. THE PATIENT AND PATIENT'S SPOUSE WERE EDUCATED BY THE REGISTERED NURSE (RN) UPON DISCHARGE FROM THE HOSPITAL ON SATURDAY, ON (B)(6) 2025, THE PUMP STILL HAD 60-HOURS LEFT. THE PUMP HAD BEEN INFUSING FOR 24-HOURS ALREADY. THE RN ASSESSED THE PATIENT AND THERE WERE NO SIGNS AND SYMPTOMS NOTED FROM THE FAST FLOW EVENT. THERE WAS NO REPORTED INJURY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21882089 ↗
• MalfunctionNov 27, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN FLOW RATE: UNKNOWN PROCEDURE: UNKNOWN CATHPLACE: UNKNOWN IT WAS REPORTED THE PATIENT "WENT TO SLEEP AND WOKE UP SIX HOURS LATER TO AN EMPTY BALL AND A GIANT BALL OF FLUID IN HIS LEG (ADDUCTOR CANAL BLOCK)."

  Patient problems: Foreign Body In Patient

  MAUDE report 20799671 ↗
• MalfunctionDec 28, 2023Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2023-00113 FOR THE FIRST REPORT. REFER TO 2026095-2023-00115 FOR THE THIRD REPORT. FILL VOLUME: 600 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE PUMP EMPTIED AT LEAST A DAY PRIOR TO WHAT WAS EXPECTED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18408676 ↗
• MalfunctionDec 28, 2023Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2023-00113 FOR THE FIRST REPORT. REFER TO 2026095-2023-00114 FOR THE SECOND REPORT. FILL VOLUME: 600 ML . FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE PUMP EMPTIED AT LEAST A DAY PRIOR TO WHAT WAS EXPECTED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18408675 ↗
• MalfunctionDec 28, 2023Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2023-00114 FOR THE SECOND REPORT. REFER TO 2026095-2023-00115 FOR THE THIRD REPORT . FILL VOLUME: 600 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE PUMP EMPTIED AT LEAST A DAY PRIOR TO WHAT WAS EXPECTED. ONE PATIENT EXPERIENCED SYMPTOMS OF LOCAL ANESTHETIC SYSTEMIC TOXICITY (LAST). NO MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18408670 ↗
• MalfunctionSep 1, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 600 ML; FLOW RATE: 10ML/HR; PROCEDURE: FULL HYSTERECTOMY SURGERY; CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT "WOKE UP, PUMP WAS EMPTY. DIAL WAS ON 10[CC/HR]. [THE PATIENT] IS GOING TO REMOVE BUT CATHETER GLUED IN. ADVISED TO PLACE WARM MOIST TOWEL OVER SITE TO LOOSEN GLUE. [PATIENT] DENIES METAL TASTE, RINGING IN EARS OR NUMBNESS AROUND LIPS." THERE WAS NO REPORTED INJURY. THE PATIENT REPORTS " EXPERIENCING NO SYMPTOMS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671686 ↗
• MalfunctionJun 5, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FLOW RATE: 2-14ML/HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060650 ↗
• MalfunctionApr 18, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 750 ML . FLOW RATE: 14 ML/HR. PROCEDURE: UNKNOWN . CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. 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 2026095-2023-00051 FOR THE FIRST REPORT. REFER TO 2026095-2023-00052 FOR THE SECOND REPORT. IT WAS REPORTED, THE OUTPUT ON THE ON-Q, SELECT-A-FLOW WAS MUCH HIGHER THAN THE HIGHEST SETTING, WHEN SET TO 14ML/HR, THE ACTUAL OUTPUT RANGED FROM 23 ML/HR TO 25 ML/HR. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766111 ↗
• MalfunctionApr 18, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 750 ML. FLOW RATE: 14 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. 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 2026095-2023-00051 FOR THE FIRST REPORT. REFER TO 2026095-2023-00053 FOR THE THIRD REPORT. IT WAS REPORTED, THE OUTPUT ON THE ON-Q, SELECT-A-FLOW WAS MUCH HIGHER THAN THE HIGHEST SETTING, WHEN SET TO 14ML/HR, THE ACTUAL OUTPUT RANGED FROM 23 ML/HR TO 25 ML/HR. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023 REPORTED, THE PATIENT WAS STABLE AND HAD BEEN DISCHARGED, THERE WAS NO REPORTED ADVERSE EVENTS, ONLY THE OVER-INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761029 ↗
• MalfunctionApr 17, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 750 ML. FLOW RATE: 14 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. 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 2026095-2023-00052 FOR THE SECOND REPORT. REFER TO 2026095-2023-00053 FOR THE THIRD REPORT. IT WAS REPORTED, THE OUTPUT ON THE ON-Q, SELECT-A-FLOW WAS MUCH HIGHER THAN THE HIGHEST SETTING, WHEN SET TO 14ML/HR, THE ACTUAL OUTPUT RANGED FROM 23 ML/HR TO 25 ML/HR. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 24MAR2023 REPORTED, THE PATIENT WAS STABLE AND EXPECTED TO BE DISCHARGED IN 24-HOURS THERE WAS NO REPORTED ADVERSE EVENTS, ONLY THE OVER-INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16758717 ↗
• MalfunctionApr 7, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 600 ML. FLOW RATE: 14CC/HR. PROCEDURE: THORACOTOMY. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT, INVOLVING DIFFERENT DEVICE. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2023-00048 FOR THE FIRST REPORT IT WAS REPORTED, THERE WAS A SECOND ¿FREE FLOW¿ EVENT, WITH A SECOND PUMP ON THE SAME PATIENT; THE PUMP WAS REPORTED TO BE RUNNING AT DOUBLE THE RATE. THERE WAS NO REPORT OF INJURY, ADVERSE EVENT NOR MEDICAL INTERVENTION; THE PATIENT IS 'FINE'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701460 ↗
• MalfunctionApr 7, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 600 ML, FLOW RATE: 14CC/HR, PROCEDURE: THORACOTOMY, CATHPLACE: UNKNOWN, INFUSION START TIME: (B)(6) 2023, INFUSION STOP TIME: (B)(6) 2023. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT, INVOLVING DIFFERENT DEVICE. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2023-00049 FOR THE SECOND REPORT. A FREE FLOW WAS REPORTED, WITH THE ON-Q PUMP; THE PATIENT HAD A THORACOTOMY ON 17MAR2023, AND THE PUMP WAS SET TO 14 CC/HR, IT WAS EMPTY THE FOLLOWING MORNING. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED 21MAR2023 REPORTED, THE PATIENT WAS ¿FINE; THERE WAS NO INJURY, NO SYMPTOMS AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701458 ↗
• MalfunctionSep 26, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 750 ML, FLOW RATE: 10ML/HR , PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE 750ML ON-Q PUMP EMPTIED OUT IN LESS THAN 42-HOURS WITH THE RATE SET AT 10ML/HR. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15488129 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 600 ML, FLOW RATE: 8 ML/HR, PROCEDURE: ACL RECONSTRUCTION, CATHPLACE: FEMORAL NERVE CATHETER, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A PATIENT WITH AN ON-Q PUMP EXPERIENCED SOME CONCERNING SIDE EFFECTS: RINGING IN THE EARS, TINGLING TO BILATERAL FEET AND ITCHING TO THE UPPER THIGH. ADDITIONAL INFORMATION RECEIVED 08APR2022 REPORTED THAT THE INFUSION WAS STOPPED, THE CATHETER WAS REMOVED AND THE PATIENT IS AT HOME AND DOING WELL; THE SYMPTOMS RESOLVED.

  Patient problems: Itching Sensation; Tinnitus

  MAUDE report 14306144 ↗
• MalfunctionMar 10, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 600 ML . FLOW RATE: 8ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. DRUG: 0.2% ROPIVACAINE. IT WAS REPORTED THAT THE PUMP EMPTIED 24 HOURS SOONER THAN EXPECTED. THE PATIENT EXPERIENCED PAIN AFTER THE PUMP WAS EMPTIED AND WAS GIVEN OXY/ACETAMINOPHEN MORE OFTEN THAN ANTICIPATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Pain

  MAUDE report 13725125 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 750 ML. FLOW RATE: 8ML/HR . PROCEDURE: TOTAL KNEE. CATHPLACE: KNEE. IT WAS REPORTED THE PATIENT WAS HAVING PAIN AT INSERTION SITE. THE INSERTION SITE AREA WAS RED, EDEMATOUS AND WARM TO TOUCH. NO DRAINAGE WAS NOTED. THE PUMP WAS REMOVED WITH NO ISSUES. THE PUMP WAS REMOVED ON FRIDAY MORNING AND THE PATIENT WENT TO THE ER (EMERGENCY ROOM) ON SUNDAY. THE PATIENT WAS TREATED IN ER FOR CELLULITIS; TWO IV ANTIBIOTICS IN THE ER, SENT HOME ON ORAL ANTIBIOTIC (BACTRIM). THE AREA HAS A "HARD LARGE KNOT" AND WAS VERY RED AND SWOLLEN. THE PATIENT DENIED FEVER AND OTHER SYMPTOMS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Swelling/ Edema

  MAUDE report 12439088 ↗
• InjuryMay 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: 6ML/HR, 14ML/HR. PROCEDURE: WRIST SURGERY. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS FEELING ANXIOUS AND NOTICED SHORTNESS OF BREATH [SOB] AND DID NOT FEEL WELL WHEN THE PUMP WAS SET TO 14ML/HR FOR "3-4 HOURS." PUMP WAS SET TO 6ML/HR BUT TURNED UP TO 14ML/HR TO HELP WITH PAIN. PATIENT DID NOT FEEL WELL ON THE START OF DAY TWO AND FELT THE PUMP WHEN FROM A SOFTBALL SIZE TO A BASEBALL SIZE IN A MATTER OF TWO HOURS. PATIENT STATED THAT HE DID NOT RECEIVE ANY RELIEF FROM PAIN. PATIENT RECOVERED AFTER PUMP WAS REMOVED. ADDITIONAL INFORMATION RECEIVED 20-APR-2021 INDICATED THE SURGERY OCCURRED ON (B)(6) 2021. PATIENT IS STILL IN PAIN AND IS HAVING SHOULDER PAIN SINCE REMOVAL OF THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Anxiety; Dyspnea; Inadequate Pain Relief

  MAUDE report 11793031 ↗
• MalfunctionApr 29, 2021Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN FLOW RATE: 4ML/HR AND 6ML/HR PROCEDURE: ANKLE/HEEL SURGERY ON (B)(6) 2021 CATHPLACE: UNKNOWN IT WAS REPORTED THE DEVICE WAS COMPLETELY EMPTY AND THE SELECT-A-FLOW (SAF) WAS RUNNING ON 4 ML /HR FOR ABOUT 36-HOURS AND ON 6 ML/HR FOR APPROXIMATELY 12-HOURS. "PUMP WAS NOT COMPLETELY EMPTY, BUT APPEARED TOO EMPTY GIVEN RATE IT WAS SET AND TIME SINCE INSERTION." THE PUMP WAS REPLACED ON (B)(6) 2021 AT ABOUT 5 PM. PATIENT DENIED ANY ADVERSE EFFECT FROM MEDICATION. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION ON 28-APR-2021 STATED THE PATIENT HAD A BLOOD CLOT IN HIS BRAIN/STROKE AND HAD TO GO TO THE HOSPITAL. THE PATIENT'S CONDITION WAS UNKNOWN AT THIS TIME. INFORMATION RECEIVED INDICATED IT IS NOT THPOUGHT THIS INCIDENT IS RELATED TO THE RECENT PROCEDURE THE PATIENT HAS (PATIENT HAD A STROKE LAST YEAR, HAS A HISTORY OF EVENTS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749953 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 750 ML. FLOW RATE: 10ML/HR. PROCEDURE: FULL KNEE REPLACEMENT. CATHPLACE: KNEE AREA. DATE OF PROCEDURE: (B)(6) 2021. IT WAS REPORTED THE "PATIENT HAD A FEW DRIPS OF MEDICATION ON THE SKIN DURING REMOVAL AND NOW HAS SECOND DEGREE BURNS ON HIS THIGH" AND BLISTERING WAS NOTED ON THE THIGH. ADDITIONALLY, THE PATIENT REPORTED EXPERIENCING PAIN.

  Patient problems: Blister; Pain; Partial thickness (Second Degree) Burn

  MAUDE report 11252148 ↗

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