MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-06-29 for MLADICK CURVED CANNULA 4MM X 26CM MCLVX-326L manufactured by Byron Medical.
[462200]
The customer reported that this cannula broke in half while in a patient.
Patient Sequence No: 1, Text Type: D, B5
[7844860]
Upon receipt of the cannula, a visual inspection was performed. The cannula (lumen) broke approx 10mm from the handle. The cause of break could not be determined at the time of inspection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025576-2006-00003 |
| MDR Report Key | 732182 |
| Report Source | 05,06 |
| Date Received | 2006-06-29 |
| Date of Report | 2006-01-30 |
| Date of Event | 2006-01-30 |
| Date Mfgr Received | 2006-01-30 |
| Date Added to Maude | 2006-07-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN JACKSON |
| Manufacturer Street | 602 W RILLITO ST. |
| Manufacturer City | TUCSON AZ 85705 |
| Manufacturer Country | US |
| Manufacturer Postal | 85705 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MLADICK CURVED CANNULA 4MM X 26CM |
| Generic Name | ASPIRATION CANNULA |
| Product Code | GDM |
| Date Received | 2006-06-29 |
| Model Number | MCLVX-326L |
| Catalog Number | MCLVX-326L |
| Lot Number | LST |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 720490 |
| Manufacturer | BYRON MEDICAL |
| Manufacturer Address | 602 W. RILLITO ST. TUCSON AZ * US |
| Baseline Brand Name | MLADICK CURVED CANNULA 4MM X 26CM |
| Baseline Generic Name | ASPIRATION CANNULA |
| Baseline Model No | MCLVX-326L |
| Baseline Catalog No | MCLVX-326L |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-29 |