MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-09-22 for BARD BRACHY THERAPY NEEDLE 818205 manufactured by C.r. Bard, Inc..
[8093600]
No sample was returned for eval and no lot # info was provided for device history review. A previous study found that excessive force (>6lbs) was required to be applied to the cannula above what is normally experienced (1-2 lbs) in the procedure for breakage to result. An analysis of the labeling found the following: caution: needles are not intended to penetrate bone. If resistance is encountered, verify needle position. Do not push into bone; this may cause needle to bend or break. Replace needle if cannula, or point is damaged. Baseline report previously filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2006-00168 |
| MDR Report Key | 967133 |
| Report Source | 06 |
| Date Received | 2006-09-22 |
| Date of Report | 2006-09-22 |
| Date Mfgr Received | 2006-08-25 |
| Date Added to Maude | 2007-12-20 |
| 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 | VIVIAN STEPHENS, MGR |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846902 |
| Manufacturer G1 | BARD REYNOSA |
| Manufacturer Street | BLVD MONTEBELLO # 1 |
| Manufacturer City | REYNOSA, TAMUALIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD BRACHY THERAPY NEEDLE |
| Generic Name | BRACHYTHERAPY NEEDLE |
| Product Code | IWJ |
| Date Received | 2006-09-22 |
| Model Number | NA |
| Catalog Number | 818205 |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | * |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 936797 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | * COVINGTON GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-22 |