MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2004-03-25 for BLOOD GAS BLOOD COLLECTION CAPILLARY TUBE 04996974 manufactured by Bayer Corp..
[19487899]
Blood gas capillary tube shattered upon introduction to the rapidlab 865 blood gas analyzer. Specimen was from a pt with known hep c. Operator has been treated per hosp protocol. It was noted later that the operator was not using the recommended capillary tube and they may have been placing additional stress on the device with their technique.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2004-00004 |
| MDR Report Key | 517969 |
| Report Source | 01,05 |
| Date Received | 2004-03-25 |
| Date of Report | 2004-03-25 |
| Date of Event | 2004-03-15 |
| Date Mfgr Received | 2004-03-15 |
| Date Added to Maude | 2004-03-30 |
| 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 | MEDFIEDL MA 02052 |
| Manufacturer Country | US |
| Manufacturer Postal | 02052 |
| Manufacturer Phone | 5083593826 |
| Manufacturer G1 | MODULOHM A/S |
| Manufacturer Street | VASEKAER 6 - 8 |
| Manufacturer City | HERLEV 2730 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOOD GAS BLOOD COLLECTION CAPILLARY TUBE |
| Generic Name | LITHIUM HEPARINIZED CAPILLARY TUBES |
| Product Code | GIO |
| Date Received | 2004-03-25 |
| Model Number | NA |
| Catalog Number | 04996974 |
| Lot Number | 0707227 |
| ID Number | * |
| Device Expiration Date | 2005-07-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 507004 |
| Manufacturer | BAYER CORP. |
| Manufacturer Address | * E. WALPOLE MA 02032 US |
| Baseline Brand Name | BLOOD GAS BLOOD COLLECTION CAPILLAR TUBE |
| Baseline Generic Name | LITHIUM HEPARINIZED CAPILLARY TUBES |
| Baseline Model No | NA |
| Baseline Catalog No | 04996974 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-03-25 |