ON-Q* Elastomeric Pump 13667Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193494136673), received between Jul 28, 2022 and Jul 28, 2022 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2022Break; Break

  FILL VOLUME: UNKNOWN. FLOW RATE: 2 ML/HR. PROCEDURE: CESAREAN SECTION, (B)(6) 2022. CATHPLACE: LOWER ABDOMEN. IT WAS REPORTED THE CLINICIAN "APPLIED TENSION ON THE ON Q BALL TUBING AND THERE WAS SOME RESISTANCE BUT THE TUBING BEGAN TO COME OUT UNTIL IT 'SNAP[P]ED' AT THE SKIN, THE TIP IS NOT INTACT. APPROXIMATELY 2.25 CM OF THE DISTAL TUBING IS NOT ACCOUNTED FOR." ADDITIONAL INFORMATION RECEIVED 06-JUL-2022 STATING "THE PAINBALL WAS PLACED SUBFASCIALLY FROM THE RIGHT EDGE OF THE SKIN INCISION. THE FASCIA WAS THEN REAPPROXIMATED WITH RUNNING SUTURES OF #0 PDS. 3-0 PLAIN GUT WAS USED IN THE SUBCUTANEOUS TISSUE. THE SKIN WAS REAPPROXIMATED WITH INSORB STAPLES. DERMABOND WAS PLACED OVER THE INCISION AND THE PAINBALL SITE WAS SECURED WITH TEGADERM." THE PATIENT RETURNED TO THE OPERATING ROOM (OR) FOR REMOVAL OF RETAINED TIP. "THE FASCIA WAS REOPENED BY CUTTING THE SUTURE AND APPROXIMATELY HALF OF THE INCISION WAS OPENED WHEN THE PAIN BALL CATHETER WAS EASILY VISUALIZED IN ITS MIDLINE AND WAS FOUND TO BE KINKED AT THE MIDLINE. THE CATHETER WAS REMOVED. THEN, A PDS WAS USED TO REAPPROXIMATE THE FASCIAL INCISION IN A 1 LAYER CLOSURE AND THEN A 4-0 VICRYL ON KEITH NEEDLE WAS USED TO REAPPRO

  Patient problems: Foreign Body In Patient

  MAUDE report 15127252 ↗

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