MalfunctionMSH
CARDINAL HEALTH
Received Mar 24, 2020 · Event occurred Feb 21, 2020
Report 9871295 · MDR key 9871295
Device
Generic name
Respirator,surgical
Manufacturer
Cardinal Health 200, LlcModel number
N95-MLCatalog number
N95-ML
Lot number
JD12000555
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
MULTIPLE INSTANCES OF THE STRAPS BREAKING WHEN INDIVIDUAL ATTEMPTS TO DON MASK ON THE CARDINAL N95 MASKS WHICH MAKES THE MASK UNUSABLE. THIS HAS BEEN OCCURRING DURING TESTING AND WHEN USED DURING PATIENT CARE.
Description of Event or Problem
MULTIPLE INSTANCES OF THE STRAPS BREAKING WHEN INDIVIDUAL ATTEMPTS TO DON MASK ON THE CARDINAL N95 MASKS WHICH MAKES THE MASK UNUSABLE. THIS HAS BEEN OCCURRING DURING TESTING AND WHEN USED DURING PATIENT CARE.