CUTTER/CRUSHER, PILL, BLUE
Received Apr 16, 2025 · Event occurred Mar 11, 2025
Report 21847882 · MDR key 21847882
Device
Generic name
Pill Crusher/cutter
Manufacturer
Medline Industries, Inc.Model number
NON137000RCatalog 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.