MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-03-27 for BARD BRACHYTHERAPY NEEDLE 818205 manufactured by C.r. Bard, Inc..
[449620]
It was reported that during a brachytherapy implant procedure for prostate cancer, a needle broke as it was being retracted and the plunger was being pushed in. The dr. Felt a pop and the imaging showed that the needle was broken. The ultrasound probe was removed from the patient and a small incision was made in the patient's perineum and the indwelling needle piece was removed. Even though some of the needles had hit bone, the doctor did not think this was one of them. When a needle hits bone, the doctor removes the needle, repositions the needle and does not force it if he feels resistance. There were three seeds remaining in the portion of the needle that was removed from the patient. The needles for the procedure had been loaded on-site at the hospital by the customer using i-125 seeds. There were no further complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2006-00056 |
| MDR Report Key | 693086 |
| Report Source | 07 |
| Date Received | 2006-03-27 |
| Date of Report | 2006-03-22 |
| Date Mfgr Received | 2006-02-28 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2006-03-30 |
| 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, FIELD ASSUR 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 | 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 | 2006-03-27 |
| Model Number | NA |
| Catalog Number | 818205 |
| Lot Number | REPF0639 |
| ID Number | NA |
| Device Expiration Date | 2006-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 682224 |
| 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 | 818205 |
| 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. Required No Informationntervention | 2006-03-27 |