MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2004-02-20 for MULTICAP CAPILLARY TUBES 473646 manufactured by Bayer Corp..
[337247]
Two cuts have been sustained by broken tubes while capping the tubes which exposed the operator to pt blood. The blood within the capillary was not suspected to have infected operators with any desease, however, both operators are being checked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2004-00001 |
| MDR Report Key | 527724 |
| Report Source | 01,07 |
| Date Received | 2004-02-20 |
| Date of Report | 2004-02-20 |
| Date of Event | 2004-01-11 |
| Date Mfgr Received | 2004-01-21 |
| Date Added to Maude | 2004-06-03 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY GRAY |
| Manufacturer Street | MODULOHM A/S, VASEKAER 6-8 |
| Manufacturer City | HERLEV 2730 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2730 |
| Manufacturer Phone | 3593826 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTICAP CAPILLARY TUBES |
| Generic Name | LITHIUM HEPARINIZED MICRO CAPILLARY TUBES |
| Product Code | GIO |
| Date Received | 2004-02-20 |
| Model Number | NA |
| Catalog Number | 473646 |
| Lot Number | 0709221 |
| ID Number | * |
| Device Expiration Date | 2005-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 516898 |
| Manufacturer | BAYER CORP. |
| Manufacturer Address | * WALPOLE MA 02032 US |
| Baseline Brand Name | MULTICAP CAPILLARY TUBES |
| Baseline Generic Name | LITHIUM HEPARINIZED MICRO CAPILLARY TUBES |
| Baseline Model No | NA |
| Baseline Catalog No | 473646 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-02-20 |