Halyard 13672Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651136722), received between Mar 15, 2017 and Mar 4, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2019Infusion or Flow Problem; Infusion or Flow 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 2026095-2019-00034 FOR THE FIRST EVENT. FILL VOLUME: 270 ML, FLOW RATE: 4 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, START DATE/TIME: (B)(6) 2019 AT 1255, STOP DATE/TIME: (B)(6) 2019 AT 0200. IT WAS REPORTED THE ON-Q DEVICE RAN OUT SOONER THAN EXPECTED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2019 STATED THE REPORTING PHARMACIST CALLED TO NOTIFY THAT THE SAMPLE WAS DISCARDED AND NOT AVAILABLE TO RETURN ANYMORE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8388570 ↗
• MalfunctionMar 2, 2019Infusion or Flow Problem; Infusion or Flow 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 2026095-2019-00035 FOR THE SECOND EVENT. FILL VOLUME: 270 ML, FLOW RATE: 4 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, START DATE/TIME: (B)(6) 2019 AT 0800, STOP DATE/TIME: (B)(6) 2019 AT 2054. IT WAS REPORTED THE ON-Q DEVICE RAN OUT IN LESS THAN 40-HOURS, ACCORDING TO PHARMACY THE DEVICE SHOULD OF LASTED 67-HOURS. UPON ASSESSMENT, THERE WAS NO LEAK FOUND AT THE INSERTION SITE. ADDITIONAL INFORMATION RECEIVED (B)(6) 2019 STATED THE REPORTING PHARMACIST CALLED TO NOTIFY THAT THE SAMPLE WAS DISCARDED AND NOT AVAILABLE TO RETURN ANYMORE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8384680 ↗
• MalfunctionJan 17, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 270 ML. FLOW RATE: UNKNOWN. PROCEDURE: ABDOMINOPLASTY. CATHPLACE: UNKNOWN. DATE/TIME INFUSION START: (B)(6) 2019 AT 1:00PM, DATE/TIME INFUSION STOP: 48-HOURS AFTER SURGERY (B)(6) 2019. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2019 STATED THE OPERATING ROOM (OR) NURSE "CUT OFF THE WHITE CLIPS AND DISPOSED OF THE PUMP". THE PATIENT REPORTED THAT THE DEVICE INFUSED IN 48-HOURS. ADDITIONAL INFORMATION RECEIVED (B)(6) 2019 STATED THE DEVICE WAS CARRIED IN ON-Q BAG SECURED THE AROUND PATIENT'S WAIST. ADDITIONAL INFORMATION RECEIVED (B)(6) 2019 STATED THE PUMP WAS FILLED "THE BEFORE OR THE MORNING OF THE SAME DAY OF USE". THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8259314 ↗
• InjuryMar 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 125 ML, FLOW RATE: 4 ML/HR, PROCEDURE: RIB PLATING, CATHPLACE: UNKNOWN, PUMP START TIME: (B)(6) 2017 UNKNOWN TIME, PUMP STOP TIME: (B)(6) 2017 5:36 PM. IT WAS REPORTED THAT A INTENSIVE CARE UNIT PATIENT EXPERIENCED A SEIZURE IN THE EARLY MORNING 12-HOURS AFTER USING THE ELASTOMERIC PUMP, WHICH FOLLOWED HER RIB PLATING PROCEDURE. THE PUMP WAS PLACED ON (B)(6) 2017, AND WAS NOT LABELED WITH WHAT MEDICATION WAS IN THE PUMP. THE PUMP WAS PULLED ON THE NIGHT OF (B)(6) 2017 AND WAS DISCARDED. IT WAS UNKNOWN IF THE PATIENT EXPERIENCED ANYMORE SEIZURES, AND THERE WAS NO FURTHER REPORT ON THE PATIENT'S STATUS. ADDITIONAL INFORMATION RECEIVED ON 28-FEB-2017 STATED THAT AN INTERNAL INVESTIGATION WAS PERFORMED AND IT WAS DISCOVERED THAT THE SEIZURE WAS NOT RELATED TO THE USE OF THE PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Seizures

  MAUDE report 6407611 ↗

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