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 manufactured by Radiometer Medical Aps.
[3109238]
A kids-nurse cut herself on used glass capillary tube when it broke during use.
Patient Sequence No: 1, Text Type: D, B5
[10366363]
The nurse is going to be vaccinated additionally two more times.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2012-00015 |
| MDR Report Key | 2889194 |
| 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, RA SPECIALIST |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| 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 |
| 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 |