Halyard 94842Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651948424), received between Apr 27, 2018 and Jan 6, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2020Obstruction of Flow; Obstruction of Flow

  AN FDA USER FACILITY REPORT #(B)(4) WAS RECEIVED, ALERT DATE 11 DEC 2019. THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT SCHEDULED FOR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT AND ADMITTED FOR OBSERVATION AND USE OF TUBE PRIOR TO DISCHARGE. THE TUBE WAS NEVER FULLY FUNCTIONING (UNABLE TO FLUSH A TYPICAL VOLUME OF MEDICATION OR FORMULA). SEVERAL ATTEMPTS WERE MADE TO DISLODGE TUBE AND/OR ADJUST TUBE WITHOUT SUCCESS. SURGICAL TEAM WAS CONSULTED, WHO ALSO ATTEMPTED TO DISLODGE/ADJUST THE TUBE. PATIENT REQUIRED SURGICAL INTERVENTION TO REPLACE TUBE. TUBE WAS FOUND TO BE DEFECTIVE WITH A SMALL MEMBRANE THE LUMEN OF THE TUBE PARTIALLY OCCLUDING THE FLOW. PATIENT REQUIRED THREE ADDITIONAL DAYS OF HOSPITALIZATION FOLLOWING SURGICAL INTERVENTION. EVENT DATE: (B)(6) 2019. THE DEICE WAS IN USE FOR ONE DAY. ADDITIONAL INFORMATION RECEIVED 17-DEC-2019 STATED THE PATIENT HAD NO RESIDUAL ISSUES FROM THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 9551032 ↗
• InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A SUSPECTED ALLERGY TO SILICONE. THE GASTROSTOMY TUBE WAS INSERTED IN (B)(6) 2017. TWO WEEKS LATER THE PATIENT DEVELOPED CELLULITIS AND VOMITING, SUBSEQUENTLY THE FEEDING SOLUTION AMOUNT WAS CHANGED THE PATIENT RECEIVED ANTIBIOTICS AND TOPICAL MUPIROCIN AND THE CELLULITIS WENT AWAY. IN (B)(6) 2017 THE PATIENT DEVELOPED REDNESS, PAIN AND INFLAMMATION. THE PATIENT RECEIVED ANOTHER ROUND OF TOPICAL MEDICATIONS, DRYING DRESSING, CAVILON SPRAY FOR THE SKIN AND DOMEBORO POWDER.

  Patient problems: Cellulitis; Hypersensitivity/Allergic reaction; Vomiting

  MAUDE report 7470363 ↗