MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for EZ-IO POWER DRIVER 9058 manufactured by Teleflex Medical.
[188653736]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[188653737]
The report states: we have a bad drill that was put into service not that long ago. It was being used on a live patient, but the customer did not have any other information and did not have the driver on hand for sn/lot. When asked if the green light was turning on and he was not sure. When asked if the user was aware that they could manually insert the needle he was not sure of that either. Additional information: the customer sent me the driver sn: (b)(4). It looks like the manufactured year was 2011 which would make sense that this driver is dated. But he did say the green light is on and that it was tried and failed on 2 different patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2020-00093 |
| MDR Report Key | 9864929 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-03-20 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2020-03-23 |
| Catalog Number | 9058 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |