MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2004-03-16 for MULTICAP CAPILLARY TUBES 473646 manufactured by Bayer Corp.
[15443746]
Operator exposed to pt blood while capping microcapillary tubes. Operator has been treated per hospital protocol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2004-00003 |
| MDR Report Key | 534412 |
| Report Source | 01,07 |
| Date Received | 2004-03-16 |
| Date of Report | 2004-03-15 |
| Date of Event | 2004-03-04 |
| Date Added to Maude | 2004-07-16 |
| 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 | * |
| Manufacturer City | MEDFIELD MA 02052 |
| Manufacturer Country | US |
| Manufacturer Postal | 02052 |
| Manufacturer Phone | 5083593826 |
| Manufacturer G1 | * |
| Manufacturer Street | MODULOHM A/S, VASEKAER 6-8 |
| Manufacturer City | HERLEV 2370 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2370 |
| 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 | 2004-03-16 |
| 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 | 523680 |
| 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 | 2004-03-16 |