inforMED
MalfunctionOHY

CUTTER/CRUSHER, PILL, BLUE

Received Apr 16, 2025 · Event occurred Mar 11, 2025

Report 21847882 · MDR key 21847882

Device

Generic name

Pill Crusher/cutter

Model number

NON137000R

Catalog number

NON137000R

Lot number

13524080029

Product problems

  • Contamination of Device Ingredient or Reagent

Patient

8 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

[SITUATION]: THE NEWLY STOCKED PILL CRUSHER IS LEAVING PLASTIC RESIDUE IN CRUSHED/GROUND MEDICATIONS. B [BACKGROUND]: A FORMERLY STOCKED COMBO PILL CRUSHER/SPLITTER LEFT PLASTIC RESIDUE IN CRUSHED/GROUND MEDICATIONS. [ASSESSMENT]: PATIENT SAFETY IS AT RISK. THE SHREDS OF PLASTIC ARE NOT EASILY REMOVED FROM THE CRUSHED DOSE. IN ADDITION, DOSE MAY BE LOST TO PLASTIC REMOVAL. [RECOMMENDATION]: RUSH ORDER OF 5 SILENT KNIGHTS, 1 PER OMNICELL ALCOVE FOR EACH INPATIENT REGION. ORG-LEVEL PURCHASE OF SILENT KNIGHT CRUSHERS FOR EACH PATIENT ROOM SINCE PILL CRUSHING IS A HOUSE-WIDE NEED. WITH PHARMACY SUPPORT, EXPLORATION OF COMMUNITY RESOURCES FOR PILL CRUSHING AT HOME SINCE THE PRACTICE IS OFTEN AFFIRMED AT DISCHARGE. RECOUP OF ANY COSTS FROM PRODUCT SUPPLIER AS TWO PRODUCT OPTIONS HAVE NOW PROVEN DEFECTIVE AND UNSAFE.

Additional Manufacturer Narrative

THE FOLLOWING ELEMENTS HAVE BLANK DATA: [DEVICE MODEL #:] FOR TYPE OF DEVICE: PILL CRUSHER/CUTTER. [DEVICE IDENTIFIER (DI):] FOR TYPE OF DEVICE: PILL CRUSHER/CUTTER. [DEVICE CATALOG (REF) #:] FOR TYPE OF DEVICE: PILL CRUSHER/CUTTER.

Description of Event or Problem

S [SITUATION]: THE NEWLY STOCKED PILL CRUSHER IS LEAVING PLASTIC RESIDUE IN CRUSHED/GROUND MEDICATIONS. B [BACKGROUND]: A FORMERLY STOCKED COMBO PILL CRUSHER/SPLITTER LEFT PLASTIC RESIDUE IN CRUSHED/GROUND MEDICATIONS A [ASSESSMENT]: PATIENT SAFETY IS AT RISK. THE SHREDS OF PLASTIC ARE NOT EASILY REMOVED FROM THE CRUSHED DOSE. IN ADDITION, DOSE MAY BE LOST TO PLASTIC REMOVAL. R [RECOMMENDATION]: RUSH ORDER OF 5 SILENT KNIGHTS, 1 PER OMNICELL ALCOVE FOR EACH INPATIENT REGION. ORG-LEVEL PURCHASE OF SILENT KNIGHT CRUSHERS FOR EACH PATIENT ROOM SINCE PILL CRUSHING IS A HOUSE-WIDE NEED. WITH PHARMACY SUPPORT, EXPLORATION OF COMMUNITY RESOURCES FOR PILL CRUSHING AT HOME SINCE THE PRACTICE IS OFTEN AFFIRMED AT DISCHARGE. RECOUP OF ANY COSTS FROM PRODUCT SUPPLIER AS TWO PRODUCT OPTIONS HAVE NOW PROVEN DEFECTIVE AND UNSAFE.