ON-Q* Pain Relief System 13627Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00193494136277), received between Sep 22, 2022 and Aug 8, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2023-00086 FOR THE FIRST EVENT. FILL VOLUME: UNKNOWN; FLOW RATE: UNKNOWN; PROCEDURE: UNKNOWN; CATHPLACE: UNKNOWN. IT WAS REPORTED THE "PUMP WAS REMOVED IN [A] HOSPITAL BEFORE DISCHARGED. THE WOUND SIDE HAD NO INFECTION. BUT WHEN PATIENT [TRAVELED], [THE PATIENT] REALIZED THAT [THE] WOUND WAS INFECTED...DID A CULTURE SWAB... AND IT WAS STAPH AUREUS." ADDITIONAL INFORMATION RECEIVED 24-JUL-2023 STATED THE PATIENT IS REPORTED TO BE WELL.

  Patient problems: Bacterial Infection

  MAUDE report 17483764 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2023-00087 FOR THE SECOND EVENT. FILL VOLUME: UNKNOWN; FLOW RATE: UNKNOWN; PROCEDURE: THBSO, OMENTECTOMY, APPENDECTOMY, AND NODAL SAMPLING; CATHPLACE: UNKNOWN. IT WAS REPORTED THE "PUMP WAS REMOVED IN [A]HOSPITAL BEFORE DISCHARGED. THE WOUND SIDE HAD NO INFECTION. BUT WHEN PATIENT [TRAVELED], [THE PATIENT] REALIZED THAT [THE] WOUND WAS INFECTED...DID A CULTURE SWAB... AND IT WAS STAPH AUREUS." ADDITIONAL INFORMATION RECEIVED 24-JUL-2023 STATED THE MEDICAL INTERVENTION ENTAILED "ASPIRATION OF THE HEMATOMA." THE PATIENT IS REPORTED TO BE WELL.

  Patient problems: Bacterial Infection; Hematoma

  MAUDE report 17483762 ↗
• MalfunctionJan 6, 2023Break; Break

  IT WAS REPORTED TIT WAS REPORTED THAT THE ON-Q CATHETER BROKE DURING PATIENT USE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16118367 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2022-00105 FOR THE SECOND EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNDERNEATH SUBCUTANEOUS. IT WAS REPORTED THE PATIENT EXPERIENCED AN EVENT OF A LARGE AMOUNT OF GREEN DISCHARGE, SEVERE FEVER AND EXOTHERMIC INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTIC INJECTION. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 STATED THE PATIENT HAS SINCE RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Fever; Purulent Discharge

  MAUDE report 15465053 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00104 FOR THE FIRST EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNDERNEATH SUBCUTANEOUS. IT WAS REPORTED THE PATIENT EXPERIENCED AN EVENT OF A LARGE AMOUNT OF GREEN DISCHARGE, SEVERE FEVER AND EXOTHERMIC INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTIC INJECTION. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 STATED THE PATIENT HAS SINCE RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Fever; Purulent Discharge

  MAUDE report 15464935 ↗

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