inforMED
MalfunctionOFR

MEDLINE

Received Apr 9, 2026 · Event occurred Mar 10, 2026

Report 1417592-2026-00399 · MDR key 24830877

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Product code (OFR)
Manufacturer (Medline Industries, Lp - Northfield)
Model (DYND40970)

Device

Generic name

Kit,catheter,suction,10fr,whistl,2 Glv

Catalog number

DYND40970

Lot number

48625060001

Product problems

  • Break

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER CONTACT ON (B)(6) 2026, "THE RN WAS UTILIZING THE 10FRENCH SUCTION CATHETER TO SUCTION THE PATIENT'S MOUTH. WHILE SUCTIONING SHE NOTED THAT 2 PIECES OF THE SUCTION CATHETER HAD BROKEN OFF IN THE PATIENT'S MOUTH. THE PATIENT WAS NOT BITING ON THE CATHETER. THERE WAS NOT HARM TO THE PATIENT. THE RN REMOVED THE PIECES OF THE CATHETER FROM THE PATIENT'S MOUTH. THE PATIENT HAD NO DIFFICULTY BREATHING AND DID NOT CHOKE ON THE SUCTION CATHETER PIECES. NO FOLLOW UP CARE OR MEDICAL/SURGICAL TREATMENT WAS NEEDED. THE PATIENT IS DOING WELL, NO ISSUES". NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER CONTACT ON (B)(6) 2026, "THE RN WAS UTILIZING THE 10FRENCH SUCTION CATHETER TO SUCTION THE PATIENT'S MOUTH. WHILE SUCTIONING SHE NOTED THAT 2 PIECES OF THE SUCTION CATHETER HAD BROKEN OFF IN THE PATIENT'S MOUTH".

Additional Manufacturer Narrative

UPDATE TO H6: TYPE OF INVESTIGATION (B). UPDATE TO H6: INVESTIGATION FINDINGS (C). UPDATE TO H6: INVESTIGATION CONCLUSIONS (D).