MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-07 for EZ-IO 25MM NEEDLE SET-EU CONFIGURATION 9001-EU-001 manufactured by Teleflex Medical.
[135382420]
(b)(4). The complaint sample is not available for return. Functional testing and investigation activities cannot be conducted. The complaint root cause cannot be established. The complaint cannot be confirmed. The device history review file is not available for review in the us. The ifu states, "attach luer-lock syringe to hub of catheter. Withdraw the catheter by applying traction while rotating the syringe and catheter clockwise. Maintain axial alignment during removal. Do not rock or bend the catheter. " a review of the certificate of compliance could not be accomplished as the product lot number was not reported. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[135382421]
It was reported that a patient has had an io needle removed from the shin/tibia but the needle snapped and the needle fragments were retained in the shin/tibia. The patient will require an operation to remove the needle fragments when he is more stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2019-00049 |
| MDR Report Key | 8315761 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-07 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-12-21 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2019-02-07 |
| 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 25MM NEEDLE SET-EU CONFIGURATION |
| Generic Name | TUBING, PRESSURE AND ACCESSORI |
| Product Code | BYX |
| Date Received | 2019-02-07 |
| Catalog Number | 9001-EU-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2019-02-07 |