MalfunctionEXR
UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Feb 23, 2015 · Event occurred Feb 10, 2015
Report 3007966929-2015-00029 · MDR key 4546676
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
158101310190Lot number
161969
Product problems
- Delivered as Unsterile Product
Patient
Not reported
- Not Applicable
Narrative
Description of Event or Problem
THE NURSE REPORTS UNPACKING THE UNOMETER SAFETI PLUS AND SAW AN OBJECT THAT LOOKED LIKE HAIR 'TRAPPED INSIDE URINE METER CHAMBER.' THE NURSE FURTHER REPORTS THE DEVICE WAS NOT USED ON A PATIENT.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 02/20/2015.