ON-Q* Pain Relief System 13630Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00193494136307), received between Jun 9, 2020 and Sep 14, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (5 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 14, 2021Material Fragmentation; Material Fragmentation

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: CAESAREAN SECTION. CATHPLACE: PRE-PERETONIUM. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT WHEN THE SILVER SOAKER CATHETER WAS REMOVED FROM THE PATIENT, A "<1CM" PIECE OF THE CATHETER WAS LEFT INSIDE THE PATIENT. THE CATHETER WAS REMOVED BY A WARD NURSE, AND THE PATIENT DID NOT EXPERIENCE ANY DISCOMFORT UPON REMOVAL. THE PATIENT'S CURRENT CONDITION WAS DESCRIBED AS "GOOD." THE NURSE REPORTED A RESISTANCE OF 2 OUT OF 5 UPON REMOVAL (WHERE 0 IS NO RESISTANCE AND 5 IS EXTREME RESISTANCE). THE SURGEON REPORTS THAT THEY WILL KEEP AN EYE ON THE PATIENT AND REMOVE THE PIECE OF THE CATHETER WITH A SMALL INCISION "IF NEED BE." BASED ON THE INFORMATION PROVIDED, THE FACILITY AT THE HOSPITAL ARE EXPERIENCED USERS OF THE DEVICE, AND THE ANESTHESIA PROVIDER HAD NO DIFFICULTY INSERTING THE CATHETER. THE CATHETER WAS SUTURED THROUGH AND UPON REMOVAL THE BROKEN END WAS CLEAN CUT IN APPEARANCE. NO DEVICES WERE USED TO REMOVE THE CATHETER, AND THE DRUG PROVIDED BY THE PUMP WAS NOT A POTENTIAL CONTRIBUTOR TO THE INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12467732 ↗
• MalfunctionJun 9, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 2026095-2020-00086 FOR THE FIRST REPORT. REFER TO 2026095-2020-00088 FOR THE THIRD REPORT. REFER TO 2026095-2020-00089 FOR THE FOURTH REPORT. REFER TO 2026095-2020-00090 FOR THE FIFTH 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 GREATER THAN 15% 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 10135367 ↗
• MalfunctionJun 9, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 2026095-2020-00086 FOR THE FIRST REPORT. REFER TO 2026095-2020-00087 FOR THE SECOND REPORT. REFER TO 2026095-2020-00089 FOR THE FOURTH REPORT. REFER TO 2026095-2020-00090 FOR THE FIFTH 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 GREATER THAN 15% 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 10135357 ↗
• MalfunctionJun 9, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 2026095-2020-00086 FOR THE FIRST REPORT. REFER TO 2026095-2020-00087 FOR THE SECOND REPORT. REFER TO 2026095-2020-00088 FOR THE THIRD REPORT. REFER TO 2026095-2020-00089 FOR THE FOURTH 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 GREATER THAN 15% FASTER THAN EXPECTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10135354 ↗
• MalfunctionJun 9, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 2026095-2020-00086 FOR THE FIRST REPORT. REFER TO 2026095-2020-00087 FOR THE SECOND REPORT. REFER TO 2026095-2020-00088 FOR THE THIRD REPORT. REFER TO 2026095-2020-00090 FOR THE FIFTH 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 GREATER THAN 15% FASTER THAN EXPECTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10135347 ↗
• MalfunctionJun 9, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 2026095-2020-00087 FOR THE SECOND REPORT. REFER TO 2026095-2020-00088 FOR THE THIRD REPORT. REFER TO 2026095-2020-00089 FOR THE FOURTH REPORT. REFER TO 2026095-2020-00090 FOR THE FIFTH REPORT. FILL VOLUME: 330 ML, FLOW RATE: 4 ML/HR, PROCEDURE: CARDIAC SURGERY, CATHPLACE: SUBCUTANEOUS, LATERAL TO EITHER SIDE OF THE STERNUM. INFUSION START TIME: (B)(6) 2019 16:20 INFUSION STOP TIME: (B)(6) 2019 10:00 IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED; THE DOSAGE WAS DELIVERED 25% FASTER THAN EXPECTED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 27-MAY-2020 INDICATED "SINGLE USE ELASTOMERIC DEVICE FILLED WITH LOCAL ANESTHETIC SOLUTION INFUSED FASTER THAN EXPECTED. THE [DEVICE] WAS USED AFTER CARDIAC SURGERY...THIS IS A DUAL CATHETER DEVICE AND WAS PLACED BY THE SURGEONS EITHER SIDE OF THE STERNOTOMY WOUND. THE PUMP WAS FILLED WITH 330MLS OF LEVOBUPIVACAINE 0.125% AS PER HOSPITAL GUIDELINES, THIS IS THE MAXIMUM FILL VOLUME FOR THIS PUMP. THE PUMP WAS CONNECTED A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135340 ↗

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