ON-Q* Elastomeric Pump 13676Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00193494136765), received between Nov 4, 2022 and Aug 28, 2023 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionAug 28, 2023Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: UNKNOWN . FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE PUMP INFUSED INTO THE PATIENT WITHIN TWO DAYS. THE PUMP USUALLY DOESN¿T EMPTY FOR FIVE DAYS. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17636062 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 550 ML. FLOW RATE: 4ML/HR. PROCEDURE: LAPAROSCOPY FOR ENDOMETRIOSIS. CATHPLACE: X2 CATHETERS PLACED BILATERAL LOWER ABDOMEN. INFUSION START TIME: (B)(6) 2022. INFUSION STOP TIME: (B)(6) 2022. IT WAS REPORTED, THAT ON (B)(6) 2022, THE PATIENT WHO HAD A DUAL ONQ PUMP DEVELOPED PAIN, SWELLING, WARMNESS, PUS, AND REDNESS AT THE CATHETER INSERTION SITE FOUR (4) DAYS POST OP (AT APPROXIMATELY 1 PM). THE PUMP WAS REMOVED DUE TO THE PATIENTS REPORTED PAIN; THE BLACK TIP(S) WAS PRESENT ON BOTH CATHETER TIPS, THE PUMP(S) WERE NOT EMPTY. THE PATIENT WAS ADVISED TO SEEK MEDICAL ATTENTION AS SOON AS POSSIBLE. THE PATIENT¿S CURRENT CONDITION WAS NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 THE PATIENT¿S MOTHER REPORTED, THE DOCTOR PRESCRIBED ANTIBIOTICS TWICE DAILY FOR 14 DAYS. ADDITIONALLY, FOUR DAYS LATER THE PATIENT WAS EXPERIENCED REDNESS, SWELLING, AND PUS TO CATHETER INSERTION SITE ON THE LEFT SIDE ONLY; THE PATIENT REPORTEDLY WAS RUNNING A LOW-GRADE FEVER OF 101°F.

  Patient problems: Bacterial Infection; Fever; Pain; Swelling/ Edema

  MAUDE report 15951782 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: UNKNOWN ML. FLOW RATE: UNKNOWN. PROCEDURE: REMOVAL OF LEFT OVARY. CATHPLACE: LAPAROTOMY PFANNENSTIEL INCISION. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE PATIENT HAD A 10CM TERATOMA REMOVED ON (B)(6) 2022; THE SURGEON REMOVED THE LEFT OVARY WITH LAPAROTOMY P-FANNENSTIEL INCISION, THE SURGEON USED P400X4D. ON (B)(6) 2022, THE ON-Q WAS EMPTY, THE CATHETER(S) WERE REMOVED AT HOME. THE PATIENT REPORTED THE CATHETER CAME OUT EASILY; 6 HOURS LATER THE PATIENT COMPLAINED OF PAIN AND SLIGHT SWELLING, THERE WAS NO BLEEDING OR OOZING FROM CATHETER SITES. ON 1(B)(6) 2022, THE PATIENT WAS ADMITTED BACK INTO THE HOSPITAL, WITH A HEMATOMA, WHERE THEY WILL UNDERGO AN ULTRASOUND AND POSSIBLE DRAINAGE OF THE SITE. ADDITIONAL INFORMATION RECEIVED ON 17 OCT 2022 THE PATIENT CONFIRMED THEY DID NOT EXPERIENCE ANY ISSUES AT THE TIME OF THE CATHETER REMOVAL. THEY ADDITIONALLY REPORTED, THEY REMAINED IN THE HOSPITAL AFTER A PROCEDURE TO DRAIN THE LEFT SIDE ABDOMINAL HEMATOMA (SITE WHERE THE CATHETER(S) WERE PLACED); AN 18G NEEDLE WAS USED. THE PATIENT¿S HEMOGLOBIN REPORTEDLY DROPPED TO 8 DUE TO INTERNAL BLEEDING, IT WAS STATED TO BE INCREASING (PRESENT VAL

  Patient problems: Discomfort; Hematoma; Pain; Swelling/ Edema

  MAUDE report 15735579 ↗

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