MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-12-09 for BARD BRACHYTHERAPY NEEDLE 818205 manufactured by C.r. Bard, Inc..
[1004199]
It was reported that during their seed procedure in (b) (6) 2008, the needle broke and part of the needle remained in the pt. The needle reportedly broke after hitting the pubic arch. The needle was loaded with one radioactive seed. A fluoroscopy was performed on the pt and it was verified that approx 6-7 cm of the needle and the one radioactive seed remained in the pt. The doctor attempted to retrieve the needle superficially, but was unsuccessful because the needle was not as close to the skin surface as originally thought. The doctor decided to leave the needle in the pt. The pt was informed.
Patient Sequence No: 1, Text Type: D, B5
[8229792]
A review of the device history record for the reported lot number found nothing that would cause or contribute to the reported problem. The sample was evaluated and measured 5. 184". The cannula length per spec is 7. 874"+/- 0. 020". The length of the cannula of the complaint sample was found out of spec due to the broken condition of the sample. Since the broken piece of the needle remains in the pt, it is unk the actual size of the remaining piece. A previous study found that excessive force (<6 lbs) was required to be applied to the cannula above what is normally experienced (1 to 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. (b) (4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2008-00081 |
| MDR Report Key | 1259515 |
| Report Source | 06 |
| Date Received | 2008-12-09 |
| Date of Report | 2008-12-05 |
| Date of Event | 2008-10-30 |
| Date Mfgr Received | 2008-11-04 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2010-02-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA CLARK |
| Manufacturer Street | 13183 HARLAND DRIVE |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 6783424868 |
| Manufacturer G1 | BARD REYNOSA |
| Manufacturer Street | BOULEVARD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| 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 |
| Product Code | IWJ |
| Date Received | 2008-12-09 |
| Returned To Mfg | 2008-11-14 |
| Model Number | NA |
| Catalog Number | 818205 |
| Lot Number | RESD0641 |
| ID Number | NA |
| Device Expiration Date | 2009-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-09 |