MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2005-05-16 for CAPILLARY ADAPTERS 906-018 * manufactured by Radiometer Medical Aps.
[387850]
A small plastic adapter is necessary in order to transfer a blood sample from a capillary tube to a blood gas analyzer type abl5. Following a transfer the user noticed that the po2 values were too high and approaching that of ambient air. A bubble was subsequently discovered in the measuring chamber. Othe tests revealed that the introduction of ambient air is possible when using the adapter. No pt was maltreated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2005-00004 |
| MDR Report Key | 603669 |
| Report Source | 01,05,06 |
| Date Received | 2005-05-16 |
| Date of Report | 2005-05-12 |
| Date of Event | 2005-03-04 |
| Date Mfgr Received | 2005-03-15 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2005-05-19 |
| 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 | LEIF GUDNITZ |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Manufacturer Phone | 8273228 |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPILLARY ADAPTERS |
| Generic Name | ADAPTOR FOR CONNECTING CAPILLARY TUBES |
| Product Code | GIO |
| Date Received | 2005-05-16 |
| Model Number | 906-018 |
| Catalog Number | * |
| Lot Number | ALL 2005 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 593512 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * * * |
| Baseline Brand Name | CAPILLARY ADAPTERS |
| Baseline Generic Name | ADAPTOR FOR CONNECTING CAPILLARY TUBES |
| Baseline Model No | 906-018 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-16 |