MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-04-14 for CLINITUBES D941G-80-140X5 942-882 manufactured by Radiometer Medical Aps..
[2125245]
On (b)(4), 2011, at 9:15 am in the emergency department within the isolation room, an auxiliary nurse was placing end caps onto the capillary when the glass broke and some of the sample was splashed into the nurse's eye. The sample was found to be (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[9137433]
User was an auxiliary nurse part of the "(b)(6)" for drawing blood. There is an incident report within the "(b)(6)" of the hospital; the person responsible in this dept is (b)(6). The report was requested but we have been told that it is confidential. The tube has been disposed of due to it being contaminated, and there are no photos of the broken tube. The patient was being held in an isolation room and no witnesses were in the room when the incident occurred. No information is available regarding if the user was properly trained. It will take months prior to knowing whether the nurse has been infected. A follow up report will be issued if this information can be obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2011-00008 |
| MDR Report Key | 2161958 |
| Report Source | 01,05 |
| Date Received | 2011-04-14 |
| Date of Report | 2011-03-17 |
| Date of Event | 2011-03-08 |
| Date Mfgr Received | 2011-03-17 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2011-07-18 |
| 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 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer Phone | 8273436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITUBES D941G-80-140X5 |
| Generic Name | GLASS CAPPILLARY BLOOD SAMPLER |
| Product Code | GIO |
| Date Received | 2011-04-14 |
| Model Number | D941G-80-140X5 |
| Catalog Number | 942-882 |
| Lot Number | R0449 |
| Device Expiration Date | 2012-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS. |
| Manufacturer Address | BRONSHOJ DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-14 |