MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-08 for BARD BRACHYSTAR SEED IMPLANT NEEDLE 818205 manufactured by C.r. Bard, Inc..
[1578159]
It was reported that when the needle was removed from the pt, the needle was cracked about 1/3 of the way up. The needle did not break off in the pt, it was intact upon removal with the exception of the crack. The dr was able to complete the procedure without any further difficulties.
Patient Sequence No: 1, Text Type: D, B5
[8467234]
A review of the device history record for the reported lot number found nothing that would cause or contribute to the reported problem. 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 | 1018233-2010-00030 |
| MDR Report Key | 1657652 |
| Report Source | 05,06 |
| Date Received | 2010-04-08 |
| Date of Report | 2010-04-09 |
| Date of Event | 2010-03-09 |
| Date Mfgr Received | 2010-03-11 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2011-04-28 |
| 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 | NYCOLE SAYER |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846969 |
| Manufacturer G1 | BARD REYNOSA |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD BRACHYSTAR SEED IMPLANT NEEDLE |
| Product Code | IWJ |
| Date Received | 2010-04-08 |
| Model Number | NA |
| Catalog Number | 818205 |
| Lot Number | RETH0167 |
| ID Number | NA |
| Device Expiration Date | 2010-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | COVINGTON GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-08 |