MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2003-07-11 for RAPIDLYTE MICRO CAPILLARY TUBES 478604 manufactured by Bayer Healthcare, Subsiduray Of Bayer Corp..
[20158106]
Bayer healthcare received customer complaint followed by customer letter about fragility of the microcapillary tubes. It was stated by the customer that users (nurses) at their hospital facility were injured by broken capillary tubes while capping the tubes which exposed them to pt blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2003-00001 |
| MDR Report Key | 471686 |
| Report Source | 00,01,05 |
| Date Received | 2003-07-11 |
| Date of Report | 2003-07-11 |
| Date of Event | 2003-06-11 |
| Date Mfgr Received | 2003-06-11 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2003-07-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY GRAY, MANAGER |
| Manufacturer Street | 63 NORTH STREET |
| Manufacturer City | MEDFIELD MA 02052 |
| Manufacturer Country | US |
| Manufacturer Postal | 02052 |
| Manufacturer Phone | 5083593826 |
| Manufacturer G1 | BAYER HEALTHCARE |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPIDLYTE MICRO CAPILLARY TUBES |
| Generic Name | LITHIUM HEPARINIZED MICRO CAPILLARY TUBES |
| Product Code | GIO |
| Date Received | 2003-07-11 |
| Model Number | NA |
| Catalog Number | 478604 |
| Lot Number | 0606230 |
| ID Number | * |
| Device Expiration Date | 2004-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 460535 |
| Manufacturer | BAYER HEALTHCARE, SUBSIDURAY OF BAYER CORP. |
| Manufacturer Address | 333 CONEY STREET WALPOLE MA 02032 US |
| Baseline Brand Name | RAPIDLYTE ARTERIAL BLOOD SAMPLERS |
| Baseline Generic Name | LITHIUM HEPARINIZED MICRO CAPILLARY TUBES |
| Baseline Model No | NA |
| Baseline Catalog No | 478604 |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-07-11 |