Halyard 13676Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651136760), received between Apr 19, 2017 and Mar 27, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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 27, 2019Break; Break

  FILL VOLUME: 400 ML, FLOW RATE: 4 ML/HR, PROCEDURE: TOTAL OPEN HYSTERECTOMY, CATHPLACE: ABDOMEN. IT WAS REPORTED THE PUMP LOOKED EMPTY YESTERDAY EVENING ON (B)(6) 2019, AND ON (B)(6) 2019 THE PATIENT WONDERED IF IT WAS REALLY EMPTY. THE DEVICE WAS ORDERED TO BE REMOVED ON (B)(6) 2019. THE PATIENT CALLED THE HOTLINE NURSE. THE PATIENT REMOVED THE PUMP FROM THE BLACK BAG AND STATED THERE WAS "NO BALL ANYMORE, IT IS A STRAIGHT TUBE." THE INFUSION SHOULD LASTED A FOUR DAYS. THE PATIENT STATED SHE NOTICED THE PUMP WAS EMPTY YESTERDAY EVENING. THE PATIENT DENIED HAVING ANY SIDE EFFECTS LIKE RINGING IN THE EARS, METAL TASTE IN THE MOUTH, TINGLING IN FINGERS AND A RACING HEART BEAT. THE PATIENT CONFIRMED SHE DID HAVE ORDERS TO REMOVE THE PUMP AT HOME WHEN THE INFUSION WAS COMPLETED. THE HOTLINE NURSE INSTRUCTED THE PATIENT ON REMOVING THE PUMP AND CATHETERS. THE HOTLINE NURSE STAYED ON THE PHONE WITH THE PATIENT UNTIL SHE REMOVED THE PUMP. THE PATIENT REMOVED THE CATHETERS EASILY AND CONFIRMED THAT EACH CATHETER HAD A BLACK TIP. THE HOTLINE NURSE INSTRUCTED THE PATIENT SHE REMOVED THE CATHETERS FULLY AND CORRECTLY. THE PATIENT HAD NO FURTHER QUESTIONS. THE FLOW RESTRICTOR WAS TAPED TO THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8457918 ↗
• MalfunctionMar 5, 2018Break; Break

  FILL VOLUME: N/A, FLOW RATE: N/A, PROCEDURE: RIGHT KNEE REPLACEMENT, CATHPLACE: ABOVE KNEE. IT WAS REPORTED THAT A CATHETER BROKE INSIDE A PATIENT DURING REMOVAL. A HOME HEALTH REGISTERED NURSE (RN) WAS REMOVING THE PUMP FROM A PATIENT AND NOTED THAT IT MAY HAVE BIN A BIT HARD TO GET OUT THAN USUAL. THE RN WAS STEADILY PULLING FIRMER, BUT NOTHING TOO UNUSUAL, BUT THEN BEGAN TO START SEE THE BLACK MARKERS BEFORE SHE AND THE PATIENT HEARD A SNAP. THE CATHETER THEN CAME OUT WITHOUT A TIP. THEY PHONED THE DOCTOR AND IT WAS STATED BY THE DOCTOR "THERE'S NOTHING I CAN DO ABOUT IT BUT JUST WAIT AND SEE." ADDITIONAL INFORMATION RECEIVED STATED THAT THE CATHETER WAS INSERTED ABOVE THE RIGHT KNEE LATERAL SITE. THE PATIENT ATTEMPTED TO REMOVE THE CATHETER HIMSELF ON (B)(6) 2018, BUT EXPERIENCED RESISTANCE. THE RN HAD THE PATIENT CHANGE POSITIONS, WARM THE AREA, AND WHEN THE CATHETER CAME OUT, IT SNAPPED. THE REMOVED PIECE WAS MEASURED AND WAS 7 CM FROM THE FIRST DOT. THE RN RETURNED TO SEE THE PATIENT A WEEK LATER AND NOTED THAT HE WAS DOING OKAY. IT WAS DECIDED THAT NO SURGERY WAS REQUIRED TO REMOVED THE BROKEN REMNANT. NO X-RAY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7313878 ↗
• MalfunctionJan 3, 2018Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: C-SECTION, CATHPLACE: ABDOMEN. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO REMOVE THE PATIENT'S ONQ PUMP PRIOR TO THEIR DISCHARGE. HOWEVER, THE REGISTERED NURSE ENCOUNTERED DIFFICULTY WITH THE REMOVAL. THE SURGEON MADE AN ATTEMPT AT REMOVAL, BUT THE TIP BROKE OFF AND REMAINED IN THE PATIENT'S ABDOMEN. THE PATIENT, CONSEQUENTLY, REQUIRED SURGERY FOR THE REMOVAL OF THE BROKEN CATHETER TIP. ADDITIONAL INFORMATION RECEIVED ON 26-DEC-2017 STATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR A CESARIAN SECTION. THE ONQ PUMP WAS PLACED WHILE IN SURGERY FOR PAIN MANAGEMENT. THE CATHETER BROKE OFF IN THE ABDOMEN ON (B)(6) 2017. THE ACTUAL REMOVAL OF THE CATHETER BEGAN WITH THE PREVIOUS PFANNENSTIEL INCISION WHICH WAS OPENED WITH A KELLY CLAMP. THE SUTURES HOLDING THE FASCIA WERE CUT. THE PATIENT¿S ULTRASOUND THAT WAS DONE PREVIOUSLY WAS PLACED ON THE VIEWING SCREEN AND IT APPEARED THAT THE CATHETER TIP MAY BE LOCATED WITHIN THE SUBCUTANEOUS LAYER. THE AREA WAS EVALUATED WITH THE FASCIA BENEATH THE CATHETER¿S INSERTION SITE INCISED TO HELP WITH THE EVALUATION. THE TIP WAS NOT VISIBLE. THE SUTURES HOLDING THE MUSCLES WERE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7161984 ↗
• MalfunctionApr 19, 2017Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE: PROCTECTOMY LOW ANTERIOR COLON RESECTION, RIGHT SUPERFICIAL ABDOMEN. IT WAS REPORTED THAT A SHEATH BROKE OFF IN THE PATIENT AND 4 INCHES OF THE SHEATH WAS RETAINED INSIDE THE PATIENT. THE SURGEON ATTEMPTED REMOVAL, BUT WAS UNSUCCESSFUL. THE INCIDENT WAS NOTED TO HAVE OCCURRED DURING THE PEELING OF THE SHEATH. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6503367 ↗

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