MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-15 for SAFEPICO * 956-616 manufactured by Radiometer America, Inc.
[4504166]
Technician drew an arterial blood gas on patient to assess response to being on bipap. After the sample was obtained, the needle was removed and the cap placed on the syringe. The technician pushed the plunger slightly to expel any air bubbles. The blood backed up directly into the plunger. The sample was unusable and required a redraw for arterial blood gases delaying patient care. ======================manufacturer response for safepico arterial blood gases syringe, safepico (per site reporter). ======================awaiting the manufacturer's response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3820090 |
| MDR Report Key | 3820090 |
| Date Received | 2014-05-15 |
| Date of Report | 2014-05-15 |
| Date of Event | 2014-04-14 |
| Report Date | 2014-05-15 |
| Date Reported to FDA | 2014-05-15 |
| Date Reported to Mfgr | 2014-05-20 |
| Date Added to Maude | 2014-05-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFEPICO |
| Generic Name | ARTERIAL BLOOD SAMPLING |
| Product Code | CBF |
| Date Received | 2014-05-15 |
| Model Number | * |
| Catalog Number | 956-616 |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER AMERICA, INC |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-15 |