MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-06-10 for BARD BRACHYTHERAPY NEEDLE 718205 manufactured by C.r. Bard, Inc..
[21256782]
It was reported that one needle broke off in the pt during the procedure in the or. The staff was able to grasp and remove the needle bu hand as it was protruding externally from the pt's perineum. The staff could not unload the sources due to the damaged needle and therefore was unable to implant any of the seeds from this needle. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2005-00040 |
| MDR Report Key | 612779 |
| Report Source | 07 |
| Date Received | 2005-06-10 |
| Date of Report | 2005-05-10 |
| Date Mfgr Received | 2005-05-11 |
| Date Added to Maude | 2005-06-14 |
| 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 | 3 |
| Manufacturer Contact | VIVIAN STEPHENS, MANAGER |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846902 |
| Manufacturer G1 | BARD REYNOSE |
| Manufacturer Street | BOULEVARD 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 BRACHYTHERAPY NEEDLE |
| Generic Name | BRACHYTHERAPY NEEDLE |
| Product Code | IWJ |
| Date Received | 2005-06-10 |
| Model Number | NA |
| Catalog Number | 718205 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 602607 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US |
| Baseline Brand Name | BARD BRACHYTHERAPY NEEDLE |
| Baseline Generic Name | BRACHYTHERAPY NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | 718205 |
| Baseline ID | NA |
| Baseline Device Family | BARD BRACHYTHERAPY NEEDLE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| 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. Other | 2005-06-10 |