MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-12-21 for CLINITUBES 100 UL, GLASS 942-878 manufactured by Radiometer Medical Aps.
[3171500]
A kids-nurse cut herself on a used glass capillary tube when it broke during use.
Patient Sequence No: 1, Text Type: D, B5
[10523733]
The nurse is going to be vaccinated additionally two more times.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3002807968-2012-00016 |
MDR Report Key | 2987961 |
Report Source | 01,05 |
Date Received | 2012-12-21 |
Date of Report | 2012-12-03 |
Date Mfgr Received | 2012-12-03 |
Device Manufacturer Date | 2012-11-01 |
Date Added to Maude | 2013-03-25 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | LASSE MOLLER, SPECIALIST |
Manufacturer Street | AKANDEVEJ 21 |
Manufacturer City | BRONSHOJ DK-2700 |
Manufacturer Postal | DK-2700 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CLINITUBES |
Generic Name | CAPILLARY TUBES |
Product Code | GIO |
Date Received | 2012-12-21 |
Model Number | 100 UL, GLASS |
Catalog Number | 942-878 |
Lot Number | R0896 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | RADIOMETER MEDICAL APS |
Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DK-2700 DA DK-2700 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2012-12-21 |