MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-19 for EZ-IO POWER DRIVER 9058 manufactured by Teleflex Medical.
[188654101]
(b)(4). The device investigation is pending. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[188654102]
Customer reported that, patient care during trauma reanimation. Well experienced in dealing with the ez io emergency physician wants to place a 25mm i. O. Into the left proximal tibia by using the ezio power driver. During drilling with the ez-io driver of the rescue vehicle a power loss was noted (driver became slower) and finally the driver stopped. A new attempt with the same needle (which was still not completely placed) and the same driver failed in the same way. The i. O. -access was finally placed with another driver, the adrenaline application for hypodynamic circulatory arrest was delayed by 1-2 minutes. Due to the hectic pace of the situation, both devices were subsequently mixed up, so that it is no longer possible to trace which ezio driver is the defective one. No device showed a defect during the visual inspection. During a subsequent testing without drilling resistance both control lamps were green. The device with the sn (b)(4) ran subjectively a bit uneasy and strange during the test, so that this could possibly be the defective device. The devices were taken out of service after consultation with the representative safety officer and replacement was arranged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2020-00090 |
| MDR Report Key | 9855585 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-16 |
| Date of Event | 2019-10-15 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ-IO POWER DRIVER |
| Generic Name | NEEDLE, HYPODERMIC, SINGLE LU |
| Product Code | FMI |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-12 |
| Catalog Number | 9058 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |