MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-21 for CLINITUBES D957G-70-125 942-880 manufactured by Radiometer Medical Aps.
[16593024]
When the user (technician) was drawing blood from an infant the capillary broke when the end cap was being put on. The users left middle finger was punctured. Gloves were worn. The report states that the user was treated and released from the ed and sent home. No specific information regarding the treatment was given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523456-2014-00001 |
| MDR Report Key | 3723583 |
| Date Received | 2014-03-21 |
| Date of Report | 2014-01-23 |
| Date of Event | 2014-01-19 |
| Date Facility Aware | 2014-01-23 |
| Report Date | 2014-02-20 |
| Date Reported to FDA | 2014-02-21 |
| Date Reported to Mfgr | 2014-02-20 |
| Date Added to Maude | 2014-04-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 810 SHARON DR. |
| Manufacturer City | WESTLAKE OH 441451598 |
| Manufacturer Country | US |
| Manufacturer Postal | 441451598 |
| Manufacturer G1 | RADIOMETER AMERICA, INC. |
| Manufacturer Street | 810 SHARON DR. |
| Manufacturer City | WESTLAKE OH 44145159 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44145 1598 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITUBES |
| Generic Name | GLASS CAPILLARY TUBES |
| Product Code | GIO |
| Date Received | 2014-03-21 |
| Model Number | D957G-70-125 |
| Catalog Number | 942-880 |
| Lot Number | JV02 |
| Device Expiration Date | 2015-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | BRONSHOJ 2700 DA 2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-21 |