MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-11-08 for BYRON CANDY CANE CANNULA CCC 426L manufactured by Byron Medical.
[428209]
A one inch piece of cannula tip broke off in a pt during a procedure. The doctor wanted the pt to heal for a month, then have her x-rayed to determine the exact location of the tip for retrieval. Until then the remaining portion of the cannula was to be returned for evaluation. Once the tip is removed it is to be returned also. The doctors office called in 2005 to say the pt does not want the doctor to remove the tip and will seek another facility to have the piece removed. As of this report the co will not receive any pieces to evaluate until further notice from the doctors office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025576-2005-00001 |
| MDR Report Key | 645718 |
| Report Source | 05 |
| Date Received | 2005-11-08 |
| Date of Report | 2005-10-17 |
| Date of Event | 2005-10-11 |
| Date Mfgr Received | 2005-10-11 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2005-11-15 |
| 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 | STEVE CARPENTER |
| Manufacturer Street | 602 W RILLITO |
| Manufacturer City | TUCSON AZ 85705 |
| Manufacturer Country | US |
| Manufacturer Postal | 85705 |
| Manufacturer Phone | 5205730857 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BYRON CANDY CANE CANNULA |
| Generic Name | ASPIRATION CANNULA |
| Product Code | GDM |
| Date Received | 2005-11-08 |
| Model Number | CCC 426L |
| Catalog Number | CCC 426L |
| Lot Number | LST |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 635225 |
| Manufacturer | BYRON MEDICAL |
| Manufacturer Address | * TUCSON AZ 85705 US |
| Baseline Brand Name | BYRON CANDY CANE CANNULA |
| Baseline Generic Name | ASPIRATION CANNULA |
| Baseline Model No | CCC 426L |
| Baseline Catalog No | CCC 426L |
| Baseline ID | NA |
| Baseline Device Family | CANDY CANE CANNULA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-11-08 |