ON-Q* Pain Relief System 13718Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00193494137182), received between Jun 18, 2020 and Oct 29, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 300 ML, FLOW RATE: 4 ML/HR, PROCEDURE: ABDOMINOPLASTY, CATHPLACE: UNKNOWN, INFUSION START TIME: (B)(6) 2022, INFUSION STOP TIME: (B)(6) 2022. IT WAS REPORTED THAT AFTER BEING IN PLACE FOR 7 DAYS, THE ENTIRE PUMP INFUSED OVERNIGHT, (IT WENT FROM FULL CAPACITY TO COLLAPSED FLAT BY THE TIME THEY WOKE UP). THE PATIENT REPORTED WEAKNESS AND NAUSEA AFTER THE FAST FLOW INCIDENT, THE SYMPTOMS RESOLVED ON THEIR OWN; NO MEDICAL INTERVENTION REQUIRED. THE PATIENT WAS HOME AND WAS RECOVERED AS EXPECTED. THE ORIGINAL PROCEDURE WAS (B)(6) 2022.

  Patient problems: Muscle Weakness/Atrophy; Nausea

  MAUDE report 15694710 ↗
• MalfunctionDec 21, 2020Break; Break

  FILL VOLUME: UNKNOWN; FLOW RATE: UNKNOWN; PROCEDURE: ABDOMINOPLASTY; CATHPLACE: ABDOMEN. IT WAS REPORTED, "THE CATHETER BROKE OFF", WHEN THE CLINICIAN WAS REMOVING THE DEVICE FROM THE PATIENT. IT WAS NOTED THE BROKEN DEVICE COMPONENT WOULD BE REMOVED FROM THE PATIENT WHEN THE INCISION HEALS. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11046912 ↗
• MalfunctionJun 18, 2020Break; Break

  FILL VOLUME: 300 ML. FLOW RATE: UNKNOWN. PROCEDURE: BREAST AUGMENTATION. CATHPLACE: BREAST. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE CATHETER BROKE DURING REMOVAL. REMOVAL OF THE CATHETER PIECE WAS SCHEDULED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 12-JUN-2020 INDICATED "CATHETER REMOVED, PATIENT RECOVERING FINE BUT HAD TO HAVE SECOND SURGERY TO HAVE IT REMOVED." PATIENT WAS RECEIVING 0.50% BUPIVACAINE 300ML."

  Patient problems: Foreign Body In Patient

  MAUDE report 10171904 ↗

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