Halyard 13713Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651137132), received between Mar 3, 2020 and Mar 3, 2020 — classified as 3 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. 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.

• MalfunctionMar 3, 2020Break; Stretched; Break; Stretched

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2020-00029 FOR THE FIRST EVENT. REFER TO 2026095-2020-00031 FOR THE THIRD EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: CAESARIAN SECTION (C-SECTION). CATHPLACE: UNKNOWN. IT WAS REPORTED THE CATHETER "SNAPPED OFF" IN THE PATIENT¿S C-SECTION WOUND. THE CATHETER STRETCHED AND SNAPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9782048 ↗
• MalfunctionMar 3, 2020Break; Stretched; Break; Stretched

  ADDITIONAL INFORMATION RECEIVED 10-MAR-2020 STATED MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT RECEIVED SURGERY UNDER SPINAL BLOCK ANESTHESIA TO RECOVER THE BROKEN TUBE ON (B)(6) 2020 AT 1905. THE TUBE WAS SUCCESSFULLY REMOVED. THE PATIENT WAS DISCHARGED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9782046 ↗
• MalfunctionMar 3, 2020Break; Stretched; Break; Stretched

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2020-00029 FOR THE FIRST EVENT. REFER TO 2026095-2020-00030 FOR THE SECOND EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: CAESARIAN SECTION (C-SECTION), CATHPLACE: UNKNOWN. IT WAS REPORTED THE CATHETER "SNAPPED OFF" IN THE PATIENT¿S C-SECTION WOUND. THE CATHETER STRETCHED AND SNAPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9782043 ↗

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