MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-05-08 for 30328 11GX6IN BN MARR SNARECOIL NDLE * SC6011X manufactured by Ranfac Corporation.
[376449]
It was reported to tycohealthcare kendall that during a bone marrow biopsy the needle shaft broke. The doctor had to remove the needle with a pair of pliers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2004-00012 |
| MDR Report Key | 558903 |
| Report Source | 05,07 |
| Date Received | 2004-05-08 |
| Date of Report | 2004-04-09 |
| Date Facility Aware | 2004-04-09 |
| Report Date | 2004-05-07 |
| Date Mfgr Received | 2004-04-09 |
| Date Added to Maude | 2004-12-13 |
| 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 | MARTHA PORTNOW, RN |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | 2618547 |
| Manufacturer G1 | OUTSIDE VENDOR RANFAC CORP. |
| Manufacturer Street | 30 DOHERTY AVE |
| Manufacturer City | AVON MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 30328 11GX6IN BN MARR SNARECOIL NDLE |
| Generic Name | BONE MARROW BIOPSY NEEDLE |
| Product Code | LWE |
| Date Received | 2004-05-08 |
| Model Number | * |
| Catalog Number | SC6011X |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 548598 |
| Manufacturer | RANFAC CORPORATION |
| Manufacturer Address | 30 DOHERTY AVE. AVON MA 02322 US |
| Baseline Brand Name | 30328 11GX6IN BN MARR SNARECOIL NDLE |
| Baseline Generic Name | BONE MARROW BIOPSY NEEDLE |
| Baseline Model No | * |
| Baseline Catalog No | SC6011X |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-05-08 |