MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for ARROW INTERNATIONAL DILATOR CL-07024 manufactured by Arrow International.
[76841491]
The hub from 10 fr arrow dilator broke off outside the body leaving the dilator stuck inside the left femoral vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070184 |
| MDR Report Key | 6614222 |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-02 |
| Date of Event | 2017-06-01 |
| Date Added to Maude | 2017-06-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ARROW INTERNATIONAL DILATOR |
| Generic Name | DILATOR |
| Product Code | GCC |
| Date Received | 2017-06-02 |
| Model Number | CL-07024 |
| Lot Number | 14F16G0580 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL |
| Manufacturer Address | READING PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-02 |