UNOMETER BAG 3L BO (50/100)
Received Dec 19, 2013 · Event occurred Nov 20, 2013
Report 3007966929-2013-00021 · MDR key 3669798
Device
Generic name
Device, Urine Flow Rate Measuring
Manufacturer
Unomedical Ltd.Model number
MM84062182Catalog number
MM84062182
Lot number
652617
Product problems
- False Device Output
- Device Markings/Labelling Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
INFORMATION RECEIVED VIA COMPLAINT FORM INDICATES THE FOLLOWING: "SCALE ON THE REPLACEMENT URINE COLLECTING BAG FOR UNOMETER 500 IS NOT REPRESENTING THE ACTUAL CONTENTS. A NURSE NOTICED SIGNIFICANT DEVIATION AND PUT THE BAG TO THE TEST. WITH A SYRINGE, SHE FILLED 250 ML OF WATER INTO IT AND THE SCALE SHOWED APPROXIMATELY 500 ML.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF A PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. A REQUEST WAS SENT ON (B)(4) 2013 TO SUPPLIER TO INVESTIGATE THIS ISSUE. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2013. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.