MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for RADIOMETER SAFE PICO SELF FILLING ABG SYRINGE WITH SAFETY NEEDLE manufactured by Radiometer America Inc.
[133829971]
A condition c was called on the patient upon arrival the ccm ordered an abg. Upon receiving the kit and obtaining the abg, the ccm was unsure how to get the needle protector away from the needle and handed the syringe unprotected to me carefully, so that i could assist her. It was found that the needle protector that is supposed to slide easily up to cover the needle completely was not moving with even heavy pressure, and was not functioning as directed, the dirty needle was safely discarded in the red bin and we tried another kit to see if it was an isolated incident. The needle protector also wouldn? T slide on this needle as well. Information on the used needle was discarded prior to use, but the second needle that had the protector malfunction had the following information ref # 956-616 lot # bs-56 abd is a safepico self-fill abg needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083231 |
| MDR Report Key | 8261037 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-15 |
| Date of Event | 2019-01-14 |
| Date Added to Maude | 2019-01-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RADIOMETER SAFE PICO SELF FILLING ABG SYRINGE WITH SAFETY NEEDLE |
| Generic Name | ARTERIAL BLOOD SAMPLING KIT |
| Product Code | CBT |
| Date Received | 2019-01-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER AMERICA INC |
| Manufacturer Address | BREA CA 92821 US 92821 |
| Brand Name | RADIOMETER SAFE PICO SELF FILLING ABG SYRINGE WITH SAFETY NEEDLE |
| Generic Name | ARTERIAL BLOOD SAMPLING KIT |
| Product Code | CBT |
| Date Received | 2019-01-17 |
| Catalog Number | 956-616 |
| Lot Number | BS-56 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER AMERICA INC |
| Manufacturer Address | BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-17 |